510(k) K082010 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
| Applicant | Stryker Ireland Ltd., Instruments Division, Carrigtwohill, Co.Cork, IE |
| Decision | Substantially Equivalent, Dec 29, 2008 |
| Received | Jul 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2020 | Stryker Instruments Div. of Stryker Corporation Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients.
Catal Terminated |
HBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.