510(k) K943540 ยท DZJ Driver, Wire, And Bone Drill, Manual
SURGICAL CUTTING BURS
| Applicant | Stryker Corp., Portage MI, US |
| Decision | Substantially Equivalent, Nov 30, 1994 |
| Received | Jul 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2013 | Stryker Instruments Div. of Stryker Corporation REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System
Caution Federal Law (USA) restricts the device to use by or on the order of a physician
Driver, Wire and Bone Drill; T Terminated |
DZJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.