510(k) K171321 ยท OLO Orthopedic Stereotaxic Instrument
K2M Navigation Instruments
| Applicant | K2m, Leesburg VA, US |
| Decision | Substantially Equivalent, Aug 30, 2017 |
| Received | May 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2016 | K2M, Inc K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)
Product Usage:
Special Connector Instruments include an additional feature on their shafts that enable surgeo Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.