510(k) K172194 ยท NKG Posterior Cervical Screw System
Connector System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Aug 18, 2017 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2018 | Orthofix, Inc ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 Terminated |
NKG | None listed |
| Feb 23, 2018 | Orthofix, Inc ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 Terminated |
NKG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.