Tong, Skull For Traction
Regulation 882.5960
0510(k)s in 12 months (20 all time)
0recalls in 12 months (13 all time)
7recalls that name a 510(k)
Top companies in HAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Instrumed International, Inc. | 0 | 6 |
| Ossur Americas | 0 | 4 |
| Ossur Engineering, Inc | 0 | 3 |
| Jerome Medical | 2 | 0 |
| Progress Mankind Technology | 2 | 0 |
| Ace Medical Co. | 1 | 0 |
| Ace Orthopedic Manufacturing Co. | 1 | 0 |
| American Threshold Industries, Inc. | 1 | 0 |
| Applied Medical Systems | 1 | 0 |
| Bremer Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | Ossur Americas Ossur, J Tong, Sterile,
Part/ Description:
JT-115/ J TONG MED/LGE-No App;
JT-200/ J TONG ASSEMBLY SML/MED;
JT-210/ J TONG ONLY SML/MED;
JT-400/ J TONG COMPONENT TRAY Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas Ossur, Sterile,
Part/ Description:
505300T/ CB RING KIT TI SM;
505300V2/ OB V2 RING KIT TI SM;
505400T/ CB RING KIT TI STD;
505400V2/ OB V2 RING KIT TI STD;
505500T/ CB RING KIT TI LG;
505500V2/ OB Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas Ossur CB Resolve, Sterile,
Part/ Description:
505300C/ CB RESOLVE STERILE UNIT SML;
505400C/ CB RESOLVE STERILE UNIT STD;
505500C/ CB Resolve Sterile Unit LRG;
515300C/ CB RESOLVE RING KIT SM-No App Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas Ossur OB Resolve, Sterile,
Part/ Description:
505300D/ OB RESOLVE STERILE RING SML;
505400D/ OB RESOLVE RING KIT STD;
505500D/ OB RESOLVE RING KIT LRG;
515300D/ OB RESOLVE RING KIT SM-No App;
515400 Terminated |
HAX | K051918 |
| Dec 16, 2014 | Instrumed International, Inc. Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name. Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Mi Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Car Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instrume Terminated |
HAX | None listed |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 510400D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 505400D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 505300D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |
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