510(k) K200108 ยท HRS Plate, Fixation, Bone
GEO 1st MTP Joint Arthrodesis Plating System
| Applicant | Gramercy Extremity Orthopedics, LLC, Richardson TX, US |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Jan 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2023 | GRAMERCY EXTREMITY ORTHOPEDICS GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.