Home›USA›GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

USA · Richardson

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 12Class II 4Class III 0

plus 19 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 6 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

FDA 510(k) clearances by year

12017 · K161904

12019 · K182212

22020 · K202817

22021 · K212334

FDA listed device types

showing 8 of 16

Staple Driver 1Instrument, Cutting, Orthopedic 1Template 1Reamer 1Bit, Drill 1Kit, Surgical Instrument, Disposable 1Gauge, Depth 1Countersink 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212334	GEO Extremity and Ankle Plating System	2021-09-21
US	K210534	GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System	2021-03-26
US	K202817	GEO Bone Screw System	2020-10-22

GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies