Data / Medical devices / United States / Gramercy Extremity Orthopedics, LLC.

Gramercy Extremity Orthopedics, LLC.: FDA-registered device maker in Richardson, TX, United States, 7 510(k) clearances

Name: Gramercy Extremity Orthopedics, LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gramercy Extremity Orthopedics, LLC. is registered with the FDA (registration 3012478585) in Richardson, TX, United States. It lists 16 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 21, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Gramercy Extremity Orthopedics, LLC.

FDA registration number: 3012478585
Address: 1239 N Glenville Dr, Richardson, TX, United States, 75081
Owner or operator: Gramercy Extremity Orthopedics, LLC. (10053967)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: January 26, 2017
Registered through: 2026
Brand names listed: AO Handle - Cannulated, Countersink - Cannulated, Cut Guide, GEO-Desis, Single Slot, Depth Gauge, Drill Bit, Cannulated, Drill Guide, Drill Tap, Drill Tap Guide Insert and more

Devices it lists

Device	Product code	Class	Role	Source
Bender	HXW	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Reamer	HTO	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Staple Driver	HXJ	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tap, Bone	HWX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 21, 2021	K212334	GEO Extremity and Ankle Plating System	HRS	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC	accessdata.fda.gov
March 26, 2021	K210534	GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System	HRS	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC	accessdata.fda.gov
October 22, 2020	K202817	GEO Bone Screw System	HWC	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC	accessdata.fda.gov
March 26, 2020	K200108	GEO 1st MTP Joint Arthrodesis Plating System	HRS	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC	accessdata.fda.gov
January 11, 2019	K182212	Geo Staple System	JDR	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC	accessdata.fda.gov
June 20, 2017	K170571	Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw	HWC	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
January 18, 2017	K161904	GEO Bone Screw System	HWC	Substantially Equivalent	Gramercy Extremity Orthopeidics, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 4, 2023	92051	Class II	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.