Table, Surgical With Orthopedic Accessories, Manual
FDA product code JEB · Class I (low risk) · 21 CFR 878.4950 · General, Plastic Surgery
13510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905816 | Orthovision TableJEB · Traditional | American Sterilizer Co. | 03/06/1991SE |
| K900405 | Scholten FrameJEB · Traditional | Scholten Surgical Instruments, Inc. | 03/01/1990SE |
| K891917 | Ortho-J, Inc. BEK-JS-004JEB · Traditional | Ortho-J, Inc. | 05/26/1989SE |
| K891387 | Williams Belt & BootJEB · Traditional | Arthro-Medic, Inc. | 05/23/1989SE |
| K881101 | K Orthopedic TableJEB · Traditional | Instrumentation Specialties, Inc. | 04/06/1988SE |
| K880263 | Osi Rizzoli Orthopedic Table/Manual VersionJEB · Traditional | Orthopedic Systems, Inc. | 03/15/1988SE |
| K873276 | Extension Device 1416JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873275 | Extension Table 1417JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873274 | Plaster Table 1418JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873273 | Orthopaedic Table 1420JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K781082 | Cast BlockJEB · Traditional | Orthopedic Equipment Co., Inc. | 07/07/1978SE |
| K772321 | ArthrostressJEB · Traditional | Mtd, Inc. | 01/03/1978SE |
| K771020 | Spinal Surgery FrameJEB · Traditional | Orthopedic Systems, Inc. | 06/17/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1494-2019 Class II | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II…Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate… | Zimmer Surgical Inc | 04/16/2019Terminated |
| Z-0642-2018 Class II | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients…The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. | Allen Medical Systems | 10/06/2017Terminated |
| Z-0641-2018 Class II | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for…The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. | Allen Medical Systems | 10/06/2017Terminated |
| Z-0803-2018 Class II | The 2nd Assist Knee PositionerZimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the… | Zimmer Biomet, Inc. | 09/07/2017Terminated |
| Z-0372-2017 Class II | Replacement floor locking cylinders for the Schaerer model 7300 surgical tables.…The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The… | Schaerer Medical USA Inc | 09/27/2016Terminated |
| Z-0371-2017 Class II | The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached…The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were… | Schaerer Medical USA Inc | 09/27/2016Terminated |
| Z-0342-2014 Class II | TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section…The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. | Trumpf Medical Systems, Inc. | 10/28/2013Terminated |
| Z-0579-2008 | TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile…Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be… | Tenet Medical Engineering Inc | 11/23/2007Terminated |
| Z-0578-2008 | TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile…Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be… | Tenet Medical Engineering Inc | 11/23/2007Terminated |
| Z-0577-2008 | TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile…Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be… | Tenet Medical Engineering Inc | 11/23/2007Terminated |