510(k) K143320 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Apr 23, 2015 |
| Received | Nov 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2025 | Stryker Corporation The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat Open, Classified |
HBE | None listed |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | None listed |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | None listed |
| Oct 11, 2024 | Stryker Corporation 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,
decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not Open, Classified |
HBE | None listed |
| Jun 24, 2022 | Stryker Instruments Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. Open, Classified |
HBE | None listed |
| Jul 14, 2016 | Stryker Instruments Div. of Stryker Corporation 5.0mm Round Fluted Bur, Super Long Terminated |
HBE | None listed |
| Jul 14, 2016 | Stryker Instruments Div. of Stryker Corporation 6.0mm Round Fluted Bur, Super Long Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.