Operating Room Accessories Table Tray
FDA product code FWZ · Class I (low risk) · 21 CFR 878.4950 · General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
61510(k) clearances
0PMA approvals
34recalls
Manufacturers
- Mcconnell Orthopedic 14
- Orthopedic Systems, Inc. 8
- D.L. Nelson and Assoc., Inc. 3
- American Container Technology, Inc. 2
- Edgewater Medical Equipment Systems 2
- Lincoln Mills, Inc. 2
- The Anspach Effort, Inc. 2
- Devon Industries, Inc. 2
- Acufex Microsurgical, Inc. 1
- Concept, Inc. 1
- Inmed Corp. 1
- Ritmed, Inc. 1
- Stryker Corporation 1
- Biopsys Medical, Inc. 1
- Polamedco, Inc. 1
- Zimmer, Inc. 1
- Tecnol New Jersey Wound Care, Inc. 1
- Walgen Medical Innoventions 1
- Bend Orthopedic & Fracture Clinic 1
- Medmetric Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960019 | Retractor Arm ClampFWZ · Traditional | Biopsys Medical, Inc. | 02/09/1996SE |
| K945415 | 'Lil Mac Accessory Clamp(Tm)FWZ · Traditional | D.L. Nelson and Assoc., Inc. | 11/22/1994SE |
| K944779 | Carbon Lights Hand Surgery TableFWZ · Traditional | Allen Medical Systems, Inc. | 10/14/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | Andronic Devices, Ltd. | 04/15/1994SE |
| K931037 | Whitmore Vacuum-Lock Spinal Frame (VLSF-100)FWZ · Traditional | Whitmore Ent., Inc. | 07/30/1993SE |
| K926225 | Sponge CounterFWZ · Traditional | American Medical Manufacturer, Inc. | 03/05/1993SE |
| K925035 | Midkiff Geostatic ClampFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 02/18/1993SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | Orthopedic Systems, Inc. | 01/24/1991SE |
| K904826 | Tko Telescoping Lithotomy StirrupFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 10/31/1990SE |
| K897028 | Lincoln Mills Foot and Leg HolderFWZ · Traditional | Lincoln Mills, Inc. | 01/12/1990SE |
| K893969 | Decubitus Care PadFWZ · Traditional | Gulftrade Exim, Inc. | 07/14/1989SE |
| K890501 | Second AssistantFWZ · Traditional | 3M Company | 02/10/1989SE |
| K885215 | Lincoln Mills Hip HolderFWZ · Traditional | Lincoln Mills, Inc. | 01/13/1989SE |
| K884928 | Free Arm(Tm)FWZ · Traditional | Faro Medical Technologies, Inc. | 12/15/1988SE |
| K882078 | Spinal Surgery FrameFWZ · Traditional | Karlin Technology, Inc. | 06/16/1988SE |
| K880265 | Wehbe Arm HolderFWZ · Traditional | Orthopedic Systems, Inc. | 02/18/1988SE |
| K873139 | Varus and Valgus Leg HolderFWZ · Traditional | Leonard Medical, Inc. | 09/16/1987SE |
| K873370 | Allen Malleable Anesthesia ScreenFWZ · Traditional | Edgewater Medical Equipment Systems | 09/11/1987SE |
| K872900 | The Portable OrderlyFWZ · Traditional | Edgewater Medical Equipment Systems | 08/21/1987SE |
| K871840 | Mcconnell Orthopedic Ankle PositionerFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871839 | Mcconnell Orthopedic Pelvic Caliper SupportFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871824 | Mcconnell Orthopedic Suspension SystemFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871823 | Mcconnell Orthopedic Tibial PositionerFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871822 | Mcconnell Orthopedic U-Hook AssemblyFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871821 | Mcconnell Orthopedic Posterior Body SupportFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871820 | Mcconnell Orthopedic Anterior Torso-Arm SupportFWZ · Traditional | Mcconnell Orthopedic | 05/26/1987SE |
| K871819 | Mcconnell Orthopedic Shoulder/Hip PositionerFWZ · Traditional | Mcconnell Orthopedic | 05/22/1987SE |
| K871805 | Mcconnell Orthopedic Sterile Upright SupportFWZ · Traditional | Mcconnell Orthopedic | 05/19/1987SE |
| K871804 | Mcconnel Orthopedic Arthroscopy Support AssemblyFWZ · Traditional | Mcconnell Orthopedic | 05/19/1987SE |
| K871803 | Mcconnell Orthopedic Universal Positioner (Mup)FWZ · Traditional | Mcconnell Orthopedic | 05/19/1987SE |
| K871703 | Mcconnell Orthopedic Sterile Articulated ArmFWZ · Traditional | Mcconnell Orthopedic | 05/19/1987SE |
| K871225 | Hand Surgery Table ExtensionFWZ · Traditional | Orthopedic Systems, Inc. | 04/07/1987SE |
| K870104 | Radiolucent Table ExtensionFWZ · Traditional | Orthopedic Systems, Inc. | 02/06/1987SE |
| K870101 | Clark Socket, Side Rail Socket, Side Rail SectionFWZ · Traditional | Orthopedic Systems, Inc. | 02/06/1987SE |
| K870098 | Lithotomy HoldersFWZ · Traditional | Orthopedic Systems, Inc. | 02/06/1987SE |
| K865024 | Ankle Holder W/Ankle Support Kit for Leg HolderFWZ · Traditional | American Container Technology, Inc. | 01/12/1987SE |
| K864881 | Arthroscopic Ankle HolderFWZ · Traditional | Orthopedic Systems, Inc. | 12/29/1986SE |
| K864880 | Collins Positioning DeviceFWZ · Traditional | Orthopedic Systems, Inc. | 12/29/1986SE |
| K864459 | Rail Clamp Extension PieceFWZ · Traditional | American Container Technology, Inc. | 12/01/1986SE |
| K860446 | C Arm Surgical TableFWZ · Traditional | Medi-Mech, Inc. | 03/10/1986SE |
| K842700 | Basildon-Gardner Spinal FrameFWZ · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K840684 | FPP Armboard StrapFWZ · Traditional | Fpp, Inc. | 04/23/1984SE |
| K840422 | Devon Head RestFWZ · Traditional | Devon Industries, Inc. | 03/12/1984SE |
| K840421 | Ulnar Nerve ProtectorFWZ · Traditional | Devon Industries, Inc. | 03/12/1984SE |
| K833624 | Shutt Universal Stress PostFWZ · Traditional | Concept, Inc. | 11/28/1983SE |
| K832472 | Elevator CushionFWZ · Traditional | Inmed Corp. | 09/20/1983SE |
| K830272 | Protet Holders-Blocks & RollFWZ · Traditional | Ritmed, Inc. | 06/03/1983SE |
| K830707 | Acufex Universal Leg HolderFWZ · Traditional | Acufex Microsurgical, Inc. | 05/02/1983SE |
| K830612 | Chemo-TableFWZ · Traditional | Fabrications Unltd. | 03/29/1983SE |
| K821933 | Omnisurg Side Mounting Clamp & Rail Ext.FWZ · Traditional | Polamedco, Inc. | 07/08/1982SE |
| K821029 | Arthroscopy System Leg HolderFWZ · Traditional | Zimmer, Inc. | 04/29/1982SE |
| K820289 | Anthroscopic Surgical TableFWZ · Traditional | The Anspach Effort, Inc. | 04/21/1982SE |
| K820291 | Knee Support for X-Ray & SurgeryFWZ · Traditional | The Anspach Effort, Inc. | 03/05/1982SE |
| K813030 | O.R. Armboard CoverFWZ · Traditional | Tecnol New Jersey Wound Care, Inc. | 01/18/1982SE |
| K810433 | Lower Extremity Support System-LessFWZ · Traditional | Walgen Medical Innoventions | 03/13/1981SE |
| K802558 | Surcan Knee Holding DeviceFWZ · Traditional | Bend Orthopedic & Fracture Clinic | 10/31/1980SE |
| K801572 | Surg-AssistFWZ · Traditional | Medmetric Corp. | 08/04/1980SE |
| K790674 | The Surgical AssistantFWZ · Traditional | Instrument Makar, Inc. | 05/14/1979SE |
| K760456 | Table, Hand SurgiFWZ · Traditional | Stryker Corp. | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1289-2024 Class II | STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an… | Baxter Healthcare Corporation | 02/14/2024Open, Classified |
| Z-1867-2017 Class II | 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model…Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of… | Mizuho OSI | 03/28/2017Terminated |
| Z-0248-2016 Class II | Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer:…Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number… | Maquet Cardiovascular Us Sales, Llc | 08/17/2015Terminated |
| Z-0247-2016 Class II | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet…Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number… | Maquet Cardiovascular Us Sales, Llc | 08/17/2015Terminated |
| Z-1084-2015 Class II | The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product…Through an investigation of complaints, Integra found that there is the possibility for the locking handle… | Integra LifeSciences Corporation | 12/19/2014Terminated |
| Z-0412-2015 Class I | Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0406-2015 Class I | Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0398-2015 Class I | Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0392-2015 Class I | Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0352-2015 Class I | Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0328-2015 Class I | Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0274-2015 Class I | Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0271-2015 Class I | Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-2478-2014 Class I | Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2435-2014 Class I | KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2386-2014 Class I | PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2371-2014 Class I | ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd.…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2368-2014 Class I | ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 )…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2363-2014 Class I | ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2356-2014 Class I | ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12'…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2345-2014 Class I | ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2344-2014 Class I | ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20"…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2338-2014 Class I | ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-0869-2013 Class II | MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra…Integra determined there is a possibility that the Base Units may break during use. | Integra LifeSciences Corp. | 12/21/2012Terminated |
| Z-0558-2013 Class II | MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an…An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various… | Integra LifeSciences Corporation | 11/05/2012Terminated |
| Z-0627-2013 Class II | Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31…There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table. | Maquet Inc. | 11/02/2012Terminated |
| Z-2458-2012 Class II | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and…An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were… | Integra Limited | 07/27/2012Terminated |
| Z-2457-2012 Class II | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and…An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were… | Integra Limited | 07/27/2012Terminated |
| Z-1203-2012 | Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler…Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a… | Mizuho Orthopedic Systems Inc | 02/27/2012Terminated |
| Z-2336-2010 | Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences…Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but… | Integra LifeSciences Corporation | 05/19/2010Terminated |
| Z-0480-2010 | Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component…Product monitoring has determined that the connection bracket shows potential mechanical play at the OR… | Maquet Inc. | 10/22/2009Terminated |
| Z-0620-2009 | Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot…A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one… | MAQUET Inc. | 12/08/2008Terminated |
| Z-0574-2009 | Open & Unused Items - This refers to a sterilization service provided by by SterilMed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |
| Z-0780-2007 | Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s…Material used to manufacture accessory bracket does not meet product specification. The screw is normally… | Orthopedic Systems Inc | 02/14/2007Terminated |