510(k) K023959 ยท HAX Tong, Skull For Traction
JEROME GLASS RING
| Applicant | The Jerome Group, Inc., Moorestown NJ, US |
| Decision | Substantially Equivalent, Feb 21, 2003 |
| Received | Nov 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jan 2, 2009 | Ossur Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S Terminated |
LYT | None listed |
| Jan 2, 2009 | Ossur Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS Terminated |
LYT | None listed |
| Jan 2, 2009 | Ossur Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS Terminated |
LYT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.