Extremity Medical L L C

FDA Filings

This page includes the latest FDA filings for Extremity Medical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007289093
• FEI Number: 3007289093
• Name: Extremity Medical, LLC
• Owner & Operator: Extremity Medical, LLC
• Contact Address: 300 Interpace parkway, Suite 410 ; Parsippany NJ 07054 US
• Official Correspondent:
  • Brian Smekal
  • x-973-5888980-501
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 300 Interpace Pkwy Ste 410 ; Parsippany, NJ 07054 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00842078130957 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078130940 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078130933 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078130926 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078130919 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078130902 EXTREMITY MEDICAL, LLC	Omni Lapidus Plating	2024-07-26
GUDID 00842078125694 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125670 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125663 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125632 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125601 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125571 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125540 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125533 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125526 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125502 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125496 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125489 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125472 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125465 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125373 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125366 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125359 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125342 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125335 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125311 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125304 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125298 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125281 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125274 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125267 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125250 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125243 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125236 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125137 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125120 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125113 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125106 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125090 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125076 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125069 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125052 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125045 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125038 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125021 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125014 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078125007 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124994 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124871 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124864 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124857 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124833 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124826 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124819 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124802 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124796 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124789 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124772 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124765 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124758 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124635 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124628 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124611 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124598 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124581 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124574 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124567 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124550 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124543 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124536 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124529 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124512 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124499 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124482 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124475 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124468 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124451 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124444 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124437 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124420 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124413 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124406 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124390 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124383 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124376 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124369 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124352 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124345 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124338 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124321 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124314 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124307 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124291 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078124284 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078123959 EXTREMITY MEDICAL, LLC	Omni Mini	2024-07-26
GUDID 00842078110119 EXTREMITY MEDICAL, LLC	AlignX	2024-04-08
GUDID 00842078109366 EXTREMITY MEDICAL, LLC	CarpalFiX	2024-04-08
GUDID 00842078108246 EXTREMITY MEDICAL, LLC	ApeX	2024-04-08
GUDID 00842078107928 EXTREMITY MEDICAL, LLC	XMCP	2024-04-08
GUDID 00842078103142 EXTREMITY MEDICAL, LLC	IO FiX	2024-04-08
PMN K212297 Extremity Medical, LLC.	Omni Foot And Ankle Plating System	2021-08-20
PMN K211261 Extremity Medical, LLC.	Axis Charcot Fixation System	2021-05-28
PMN K201556 Extremity Medical, LLC.	Intraosseous Fixation System	2020-07-08
PMN K192592 | HWC Extremity Medical, LLC	Axis Plating System	2020-03-16
PMN K192592 | HTN Extremity Medical, LLC	Axis Plating System	2020-03-16
PMN K192592 | HRS Extremity Medical, LLC	Axis Plating System	2020-03-16
PMN K191525 | JWJ Extremity Medical, LLC	KinematX	2020-03-16
PMN K191525 Extremity Medical, LLC.	KinematX Total Wrist Arthroplasty System	2020-03-04
PMN K192592 Extremity Medical, LLC.	Axis Plating System	2019-11-21
PMN K181067 | HWC Extremity Medical, LLC	AlignX Ankle Fusion System	2018-06-07
PMN K181067 | HRS Extremity Medical, LLC	AlignX Ankle Fusion System	2018-06-07
PMN K180808 | HWC Extremity Medical, LLC	Omni Foot Plating System	2018-06-07
PMN K180808 | HRS Extremity Medical, LLC	Omni Foot Plating System	2018-06-07
PMN K181067 Extremity Medical, LLC	AlignX Ankle Fusion System	2018-05-23
PMN K180808 Extremity Medical, LLC	Omni Foot Plating System	2018-05-22
PMN K172260 Extremity Medical, LLC.	Omni Foot Plating System	2017-11-06
PMN K171018 | HWC Extremity Medical, LLC	Axis Charcot Fixation System	2017-07-24
PMN K171018 | HWC Extremity Medical, LLC	4.5/8.5 Beaming System	2017-07-24
PMN K171018 | HTN Extremity Medical, LLC	Axis Charcot Fixation System	2017-07-24
PMN K171018 | HTN Extremity Medical, LLC	4.5/8.5 Beaming System	2017-07-24
PMN K171018 Extremity Medical, LLC.	Axis Charcot Fixation System, 4.5 To 8.5mm Screw System	2017-07-13
PMN K160191 Extremity Medical, LLC	Align Anterior Ankle Fusion Plate	2016-03-25
PMN K152710 EXTREMITY MEDICAL, LLC	HammerFiX Device	2015-10-15
PMN K150309 | HWC Extremity Medical, LLC	TRIO	2015-09-03
PMN K150309 | HWC Extremity Medical, LLC	IO FiX	2015-09-03
PMN K150309 | HRS Extremity Medical, LLC	TRIO	2015-09-03
PMN K150309 | HRS Extremity Medical, LLC	IO FiX	2015-09-03
PMN K150309 EXTREMITY MEDICAL, LLC	Extremity Medical Calcaneal Osteotomy Device	2015-03-04
PMN K150166 EXTREMITY MEDICAL LLC	Extremity Medical Suture Anchor	2015-02-23
PMN K143402 EXTREMITY MEDICAL LLC	Extremity Medical Calcaneal Osteotomy Device	2015-02-04
PMN K142111 | JDR Extremity Medical, LLC	Express Staple	2014-12-23
PMN K130120 | HWC Extremity Medical, LLC	ApeX	2014-05-21
PMN K133636 | HWC Extremity Medical, LLC	HammerFiX	2014-04-02
PMN K133636 EXTREMITY MEDICAL, LLC.	EXTREMITY MEDICAL HAMMERTOE DEVICE	2014-03-28
PMN K130120 EXTREMITY MEDICAL, LLC	EXTREMITY MEDICAL IP FUSION SYSTEM	2013-04-11
KWM Extremity Medical, LLC	KinematX	2013-02-06
PMN K121417 | HWC Extremity Medical, LLC	XMCP	2012-12-18
PMN K121349 | HWC Extremity Medical, LLC	IO FiX	2012-12-18
PMN K121349 | HWC Extremity Medical, LLC	CarpalFiX	2012-12-18
LXH Extremity Medical, LLC	System Accessory	2012-12-18
HXX Extremity Medical, LLC	System Accessory	2012-12-18
HXI Extremity Medical, LLC	System Accessory	2012-12-18
HWW Extremity Medical, LLC	System Accessory	2012-12-18
HWT Extremity Medical, LLC	System Accessory	2012-12-18
HWB Extremity Medical, LLC	System Accessory	2012-12-18
HTZ Extremity Medical, LLC	System Accessory	2012-12-18
HTW Extremity Medical, LLC	System Accessory	2012-12-18
HTO Extremity Medical, LLC	System Accessory	2012-12-18
HTJ Extremity Medical, LLC	System Accessory	2012-12-18
GAC Extremity Medical, LLC	System Accessory	2012-12-18
FZX Extremity Medical, LLC	System Accessory	2012-12-18
FSM Extremity Medical, LLC	Extremity Medical surgical trays	2012-12-18
PMN K121417 EXTREMITY MEDICAL LLC	XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM	2012-07-18
PMN K121349 EXTREMITY MEDICAL LLC	IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER	2012-07-18
PMN K101700 EXTREMITY MEDICAL LLC	IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM	2010-10-12
PMN K093770 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL SCREW SYSTEM	2010-04-28
PMN K092548 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS	2009-12-15
PMN K091577 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM	2009-07-24
PMN K082934 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM	2009-04-23
PMN K083151 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL SUTURE ANCHOR	2009-01-22
PMN K081934 | HWC Extremity Medical, LLC	Jones Fracture Screws	2008-12-19
PMN K081934 | HWC Extremity Medical, LLC	CompressX	2008-12-19
PMN K081934 | HWC Extremity Medical, LLC	CompressX 2	2008-12-19
PMN K081934 EXTREMITY MEDICAL LLC	EXTREMITY MEDICAL COMPRESSION SCREW	2008-08-29

Related Finance Registrations

NCAGE Code	5T6J3	EXTREMITY MEDICAL, LLC
CAGE Code	5T6J3	EXTREMITY MEDICAL, LLC
S.A.M. Registration	5T6J3 [832720358]	EXTREMITY MEDICAL, LLC