510(k) K210377 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker iBur hubs and cutting accessories
| Applicant | Stryker Corporation, Portage MI, US |
| Decision | Substantially Equivalent, Jun 30, 2021 |
| Received | Feb 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Precision Round, Distal Bend-
Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Precision Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 2.0mm Diamond Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical ap Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Diamond Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Diamond Match Head, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medic Completed |
HBE | None listed |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Precision Match Head, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.