Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gramercy Extremity Orthopedics, LLC · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

56 daysmedian FDA review time
149 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212334GEO Extremity and Ankle Plating SystemGramercy Extremity Orthopedics, LLC2021-09-21560
K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC2021-03-26300
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC2020-10-22280
K200108GEO 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC2020-03-26691
K182212Geo Staple SystemGramercy Extremity Orthopedics, LLC2019-01-111490

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda