510(k) K061012 ยท HRS Plate, Fixation, Bone
AXSOS PLUS LOCKING PLATE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, May 19, 2006 |
| Received | Apr 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2009 | Stryker Howmedica Osteonics Corp. AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ.
The screwdrivers of the AxSOS system are multiple u Terminated |
HRS | None listed |
| Apr 13, 2009 | Stryker Howmedica Osteonics Corp. AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile.
Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ.
The torque limiter is used fo Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.