GRAMERCY EXTREMITY ORTHOPEDICS
FDA Regulatory Profile
GRAMERCY EXTREMITY ORTHOPEDICS appears in FDA public data with 1 recall, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1395-2023, Class II) was initiated on April 4, 2023. Its most recent 510(k) clearance was granted on September 21, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1395-2023 | Class II | GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis | April 4, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212334 | GEO Extremity and Ankle Plating System | September 21, 2021 |
| K210534 | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System | March 26, 2021 |
| K202817 | GEO Bone Screw System | October 22, 2020 |
| K200108 | GEO 1st MTP Joint Arthrodesis Plating System | March 26, 2020 |
| K182212 | Geo Staple System | January 11, 2019 |