510(k) K143399 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Footed Attachments and Cutting Accessories
| Applicant | Stryker Corp., Portage MI, US |
| Decision | Substantially Equivalent, May 8, 2015 |
| Received | Nov 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2016 | Stryker Instruments Div. of Stryker Corporation 2.3MM Tapered Router,
Product Number 5407-FA2-023
A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat
(ENT)/Otology /Neurotology/ Otorhinola Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.