Gramercy Extremity Orthopedics, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gramercy Extremity Orthopedics, LLC” (first 2019, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 56 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 149 |
| 2020 | 2 | 48 |
| 2021 | 2 | 43 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gramercy Extremity Orthopedics, LLC took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Gramercy Extremity Orthopedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212334 | GEO Extremity and Ankle Plating System | HRS | 2021-09-21 | 56 |
| K210534 | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System | HRS | 2021-03-26 | 30 |
| K202817 | GEO Bone Screw System | HWC | 2020-10-22 | 28 |
| K200108 | GEO 1st MTP Joint Arthrodesis Plating System | HRS | 2020-03-26 | 69 |
| K182212 | Geo Staple System | JDR | 2019-01-11 | 149 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-04-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gramercy Extremity Orthopeidics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gramercy Extremity Orthopedics, LLC?
FDA lists 5 510(k) clearances under the applicant name “Gramercy Extremity Orthopedics, LLC” (first 2019, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gramercy Extremity Orthopedics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gramercy Extremity Orthopedics, LLC is 56 days. Since 2017: 56 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gramercy Extremity Orthopedics, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 1); JDR (Staple, Fixation, Bone, 1).
Next steps
- See all 5 Gramercy Extremity Orthopedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Gramercy Extremity Orthopedics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.