Chrysalis Intelligence · Sponsors · Gramercy Extremity Orthopedics, LLC

Gramercy Extremity Orthopedics, LLC

Richardson, TX, US · 4 510(k) clearances · 1 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
4
2020-03-26 → 2021-09-21
Last 12 months
0
Product codes
2
Most recent
2021-09-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 3 2021-09-21
HWC Screw, Fixation, Bone Class II Orthopedic 1 2020-10-22
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2023-04-04
DateSeverityStatusRecall # ProductCodeReason
2023-04-04 Class II Ongoing Z-1395-2023 GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System — Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2021-09-21 K212334 GEO Extremity and Ankle Plating System HRS Class II Orthopedic
2021-03-26 K210534 GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System HRS Class II Orthopedic
2020-10-22 K202817 GEO Bone Screw System HWC Class II Orthopedic
2020-03-26 K200108 GEO 1st MTP Joint Arthrodesis Plating System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence