510(k) K040300 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Mar 3, 2004 |
| Received | Feb 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker TPS Universal Driver REF 5100- 99 Rx ,
The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone rel Terminated |
ERL | None listed |
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation CORE Universal Driver REF 5400- 99 Rx Only
This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, Terminated |
ERL | None listed |
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only
The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment ( Terminated |
ERL | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230. Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.