510(k) K051918 ยท HAX Tong, Skull For Traction
RESOLVE OPEN BACK HALO RINGS
| Applicant | Jerome Medical, Moorestown NJ, US |
| Decision | Substantially Equivalent, Aug 17, 2005 |
| Received | Jul 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.