FDA.report

Extremity Medical, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30072890933007289093Extremity Medical, LLC1Y2026-01-01300 Interpace Pkwy Building A, 2nd Floor Parsippany NJ US 07054

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
974111737041315K251128Extremity Medical External Fixation SystemKTT2025-05-07
974111454830193K250536MetaFore Small Screw SystemHWC2025-10-08
974111291246857K221362Omni Foot and Ankle Plating SystemHRS2022-06-10
974111355783184K212297Omni Foot and Ankle Plating SystemHRS2021-08-20
974111426069200K201556Intraosseous Fixation SystemHWC2020-07-08
974111305392759K192592Axis Plating SystemHRS2019-11-21
974111707311582K191525KinematX Total Wrist Arthroplasty SystemJWJ2020-03-04
974111836845403K181067AlignX Ankle Fusion SystemHRS2018-05-23
974111748615121K180808Omni Foot Plating SystemHRS2018-05-22
974111793210436K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemHWC2017-07-13
974111615651897K150309Extremity Medical Calcaneal Osteotomy DeviceHWC2015-03-04
974111622663016K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
974111079309947K133636EXTREMITY MEDICAL HAMMERTOE DEVICEHWC2014-03-28
974111074049624K130120EXTREMITY MEDICAL IP FUSION SYSTEMHWC2013-04-11
974111524170273K121417XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEMHWC2012-07-18
974111839495206K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHERHWC2012-07-18
974111738816001K081934EXTREMITY MEDICAL COMPRESSION SCREWHWC2008-08-29
974111004740776
974111266806484
974111334517819
974111334700274
974111344296245
974111351199935
974111464395358
974111597943708
974111654940158
974111736134307
974111760725671
974111768802710
974111833036772
974111935479556
974111964694558
974111971929650

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HWC92025-10-08
HRS52022-06-10
KTT12025-05-07
JWJ12020-03-04
JDR12014-12-19

PMN

GUDID

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