FDA Registration
Active
🇺🇸 United States
Extremity Medical, LLC
Reg #: 3007289093
·
FEI: 3007289093
·
Expires 2026
Products
23
Proprietary Names
24
Establishment Types
5
Classifications
23
Registration Details
- Registration Name
- Extremity Medical, LLC
- Registration Number
- 3007289093
- FEI Number
- 3007289093
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 300 Interpace Pkwy, Building A, 2nd Floor
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250536
Owner / Operator
- Firm Name
- Extremity Medical, LLC
- Operator Number
- 10027988
- Address
- 300 Interpace Parkway, Building A, 2nd Floor
- City
- Parsippany
- State
- NJ
- Postal Code
- 07054
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-03 |
| Prosthesis, Wrist, Semi-Constrained | KWM | Class 2 | Orthopedic | No | 2013-02-06 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-03-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-03-16 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2020-03-16 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-18 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-12-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-18 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2012-12-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-07-17 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2014-12-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-18 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-06-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2012-12-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-12-29 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2012-12-18 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
Proprietary Names
MetaFore Small Screw System
KinematX
Axis Plating System
System Accessory
4.5/8.5 Beaming System
Axis Charcot Fixation System
HammerFiX
TRIO
IO FiX
External Fixation System
CarpalFiX
Express Staple
Cartilaginator Joint Preparation Rasp
Extremity Medical surgical trays
Omni Mini Plating System
Omni Lapidus Plating System
ApeX
Omni Foot and Ankle Plating System
CompressX, MetaFore
APEX
XMCP
Omni Foot Plating System
AlignX Ankle Fusion System
Lapidus Instrumentation
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only
Manufacture Medical Device