Extremity Medical, LLC

FDA Device Registration & Listing · Parsippany, NJ, US · Registration 3007289093

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007289093
FEI Number
3007289093
Entity Name
Extremity Medical, LLC
City/State/Country
Parsippany, NJ, US
Establishment Address
300 Interpace Pkwy, Building A, 2nd Floor, Parsippany, NJ 07054, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Extremity Medical, LLC (Owner Number: 10027988)
Owner / Operator Contact Address
300 Interpace Parkway, Building A, 2nd Floor, Parsippany, NJ 07054, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MetaFore Small Screw System KinematX Axis Plating System KinematX System Accessory System Accessory 4.5/8.5 Beaming System Axis Charcot Fixation System HammerFiX System Accessory TRIO IO FiX System Accessory System Accessory External Fixation System IO FiX CarpalFiX Express Staple System Accessory Cartilaginator Joint Preparation Rasp Extremity Medical surgical trays Omni Mini Plating System Omni Lapidus Plating System System Accessory ApeX System Accessory System Accessory Omni Foot and Ankle Plating System CompressX, MetaFore System Accessory

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-03
KWM Prosthesis, Wrist, Semi-Constrained Orthopedic Class 2 888.3800 2013-02-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-03-16
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2020-03-16
HWT Template Orthopedic Class 1 888.4800 2012-12-18
HWB Extractor Orthopedic Class 1 888.4540 2012-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-24
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-09-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-09-03
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2012-12-18
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2012-12-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-07-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-13
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2014-12-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-18
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2026-06-15
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-01-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-01-26
HWW Countersink Orthopedic Class 1 888.4540 2012-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-05-21
HTO Reamer Orthopedic Class 1 888.4540 2012-12-18
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-12-19
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Extremity Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
8043862 AAP IMPLANTATE AG BERLIN, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007289093. Last updated year: 2026. Please use registration number 3007289093 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.