FDA.reportPublic FDA data

GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

Matched from indexed company URL: GRAMERCY EXTREMITY ORTHOPEDICS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124785853012478585GRAMERCY EXTREMITY ORTHOPEDICS, LLC.1N2026-01-011239 N Glenville Dr Richardson TX US 75081

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B471120301040Lapidus Plating System - Lapidus Medial Plate 4-Hole, RIGHT Titanium+1(855)436-2278GEOSupportCenter@gramercyortho.com
B471120302050Lapidus Plating System - Lapidus Dorsomedial Plate 5-Hole, RIGHT Titanium+1(855)436-2278GEOSupportCenter@gramercyortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2042411203440346K212334GEO Extremity and Ankle Plating SystemHRS2021-09-21
2042411242722078K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemHRS2021-03-26
2042411716658617K202817GEO Bone Screw SystemHWC2020-10-22
2042411806460463K200108GEO 1st MTP Joint Arthrodesis Plating SystemHRS2020-03-26
2042411101415180K182212Geo Staple SystemJDR2019-01-11
2042411483235166K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix ScrewHWC2017-06-20
2042411401140383K161904GEO Bone Screw SystemHWC2017-01-18
2042411207829996
2042411728466270
2042411930390798

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS32021-09-21
HWC32020-10-22
JDR12019-01-11

PMN#

GUDID#

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