Tong, Skull For Traction
FDA product code HAX · Class II (moderate risk) · 21 CFR 882.5960 · Neurology
20510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Progress Mankind Technology 2
- Jerome Medical 2
- American Threshold Industries, Inc. 1
- Pmt Corp. 1
- Ossur Americans (Formerly the Jerome Group) 1
- The Jerome Group, Inc. 1
- Spine Works 1
- Friddle'S Orthopedic Appliances, Inc. 1
- Ace Medical Co. 1
- Bremer Medical, Inc. 1
- Depuy, Inc. 1
- Levtech, Inc. 1
- Bremer Orthopedics 1
- Applied Medical Systems 1
- Codman & Shurtleff, Inc. 1
- Buckman Co., Inc. 1
- Orthopedic Systems, Inc. 1
- Ace Orthopedic Manufacturing Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090733 | PMT Halo SystemHAX · Traditional | Pmt Corp. | 07/28/2009SE |
| K071173 | Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DHAX · Special | Ossur Americans (Formerly the Jerome Group) | 05/25/2007SE |
| K051918 | Resolve Open Back Halo RingsHAX · Special | Jerome Medical | 08/17/2005SE |
| K023959 | Jerome Glass RingHAX · Traditional | The Jerome Group, Inc. | 02/21/2003SE |
| K003662 | Spine Works CollarHAX · Traditional | Spine Works | 07/09/2001SE |
| K980689 | Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional | Friddle'S Orthopedic Appliances, Inc. | 02/18/1999SE |
| K930021 | J TongsHAX · Traditional | Jerome Medical | 12/06/1995SE |
| K954069 | Ace Cervical Traction Halozs, Tongs & PinsHAX · Traditional | Ace Medical Co. | 10/12/1995SE |
| K924606 | Bremer Imaging Tongs-Mri ModelHAX · Traditional | Bremer Medical, Inc. | 09/09/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | American Threshold Industries, Inc. | 08/17/1992SE |
| K873693 | Levtech Composite Traction TongsHAX · Traditional | Levtech, Inc. | 02/05/1988SE |
| K871663 | PMT Traction TongsHAX · Traditional | Progress Mankind Technology | 06/19/1987SE |
| K864746 | Bremer Halo SystemHAX · Traditional | Bremer Orthopedics | 12/22/1986SE |
| K861470 | #Cto 100 (Cervical Traction Orthosis 100)HAX · Traditional | Applied Medical Systems | 05/02/1986SE |
| K853066 | Mayfield Disposable Skull PinsHAX · Traditional | Codman & Shurtleff, Inc. | 08/08/1985SE |
| K842680 | Ace Universal TongHAX · Traditional | Buckman Co., Inc. | 09/04/1984SE |
| K834047 | Pmt-Halo/Orthopedic Jacket SystemHAX · Traditional | Progress Mankind Technology | 02/17/1984SE |
| K822885 | Halo Traction Cervical ImmobilizationHAX · Traditional | Orthopedic Systems, Inc. | 11/22/1982SE |
| K810193 | Trippi-Wells Dual Purpose Universal TongHAX · Traditional | Ace Orthopedic Manufacturing Co. | 03/20/1981SE |
| K792586 | Halo Support Jacket & Assoc. HardwareHAX · Traditional | Depuy, Inc. | 12/31/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1002-2019 Class II | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-1001-2019 Class II | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-1000-2019 Class II | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-0999-2019 Class II | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-0555-2015 Class II | Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0554-2015 Class II | Traction tong replacement screws, non-springloaded are used in traction skull tongs for…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0553-2015 Class II | Titanium fixation screws, springloaded are used in traction skull tongs for traction…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0552-2015 Class II | Lock nuts for titanium traction tongs are used in traction skull tongs for traction used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0551-2015 Class II | Replacement screw non-springloaded traction tongs are skull tongs for traction used to…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0550-2015 Class II | Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-1509-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a…Ossur initiated the recall after their investigation of some complaints found that in some instances the… | Ossur Engineering, Inc | 11/09/2008Terminated |
| Z-1508-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a…Ossur initiated the recall after their investigation of some complaints found that in some instances the… | Ossur Engineering, Inc | 11/09/2008Terminated |
| Z-1507-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a…Ossur initiated the recall after their investigation of some complaints found that in some instances the… | Ossur Engineering, Inc | 11/09/2008Terminated |