510(k) K193129 ยท NKG Posterior Cervical Screw System
Yukon OCT Spinal System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Feb 7, 2020 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193129
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2020 | K2M, Inc Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy wh Terminated |
NKG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.