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Sign in to claim this brandExtremity Medical, LLC
United States·US-MF-000018334
Last updated September 17, 2026
What Extremity Medical, LLC makes
Extremity Medical produces orthopaedic fixation hardware, including non-bioabsorbable bone screws (both standard and non-sliding), fixation plates, and implantable bone washers for fracture stabilization. Their portfolio also includes a total wrist prosthesis for joint replacement and reusable sterilization/disinfection containers for medical devices. Additionally, they manufacture noninvasive components for external orthopaedic fixation systems.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Extremity Medical, LLC primarily manufacture?
Extremity Medical, LLC specializes in orthopaedic fixation devices. Their portfolio includes non-bioabsorbable bone screws (both standard and non-sliding types), fixation plates, implantable bone washers, and a total wrist prosthesis for joint replacement. They also produce reusable sterilization/disinfection containers for medical devices and noninvasive components for external orthopaedic fixation systems. These devices are designed to stabilize fractures and support bone healing.
Where is Extremity Medical, LLC based, and what does that mean for their regulatory oversight?
Extremity Medical, LLC is based in the United States. Since they operate within the U.S., their devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This means their products must comply with FDA requirements for safety and effectiveness, though individual devices—not the company—are authorized for use.
Which regulatory registries or databases list Extremity Medical’s devices?
Extremity Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes. This listing is part of the broader FDA compliance process for devices classified under Class I and Class II.
How are Extremity Medical’s devices classified by the FDA, and why does this matter?
Extremity Medical’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. This classification determines the regulatory pathway and scrutiny each device undergoes before authorization, ensuring appropriate oversight based on potential risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 300, Interpace Parkway, Parsippany, United States
- Website
- extremitymedical.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Brian Smekal
- EUDAMED SRN
- US-MF-000018334
- FDA FEI Number
- 3007289093
- DUNS Number
- —
Catalogue (1433)
Page 4 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Omni Stable AF | 144-35220 | FDA UDI | Class II | Active |
| Axis | 130-55135 | FDA UDI | Class II | Active |
| IO FiX | 118-50345 | FDA UDI | Class II | Active |
| CarpalFiX | 127-30226 | FDA UDI | Class II | Active |
| Axis Plate | 148-45126 | FDA UDI | Class II | Active |
| Omni | 144-35128 | FDA UDI | Class II | Active |
| Axis | 130-85125 | FDA UDI | Class II | Active |
| Axis | 130-85065 | FDA UDI | Class II | Active |
| ApeX | 121-30016 | FDA UDI | Class II | Active |
| CarpalFiX | 127-30424 | FDA UDI | Class II | Active |
| IO FiX | 118-45126 | FDA UDI | Class II | Active |
| CompressX | 101-45032-2 | FDA UDI | Class II | Active |
| KinematX | 137-47540 | FDA UDI | Class II | Active |
| Axis Plate | 148-45014 | FDA UDI | Class II | Active |
| CarpalFiX | 127-46612-SW | FDA UDI | Class II | Active |
| Omni | 144-80011 | FDA UDI | Class II | Active |
| Axis Plate | 148-35028 | FDA UDI | Class II | Active |
| IO FiX | 118-40330 | FDA UDI | Class II | Active |
| Omni | 144-35240 | FDA UDI | Class II | Active |
| Axis | 130-85060 | FDA UDI | Class II | Active |
| IO FiX | 118-65190 | FDA UDI | Class II | Active |
| Xmcp | 102-40036 | FDA UDI | Class II | Active |
| IO FiX | 118-65155 | FDA UDI | Class II | Active |
| X Ring Fixator | 156-00302 | FDA UDI | Class II | Active |
| AlignX | 136-40024 | FDA UDI | Class II | Active |
| IO FiX | 118-30020 | FDA UDI | Class II | Active |
| IO FiX | 118-65070 | FDA UDI | Class II | Active |
| IO FiX | 118-70625 | FDA UDI | Class II | Active |
| Omni | 144-60052 | FDA UDI | Class II | Active |
| Omni Mini | 154-35126 | FDA UDI | Class II | Active |
| IO FiX | 118-50250 | FDA UDI | Class II | Active |
| IO Freedom | 136-65145 | FDA UDI | Class II | Active |
| Axis | 130-75095 | FDA UDI | Class II | Active |
| IO FiX | 118-30236 | FDA UDI | Class II | Active |
| AlignX | 136-40155 | FDA UDI | Class II | Active |
| IO FiX | 118-45145 | FDA UDI | Class II | Active |
| Omni | 144-28028 | FDA UDI | Class II | Active |
| Omni Mini | 154-35145 | FDA UDI | Class II | Active |
| AlignX | 136-40126 | FDA UDI | Class II | Active |
| IO FiX | 118-65100 | FDA UDI | Class II | Active |
| Omni Mini | 154-35130 | FDA UDI | Class II | Active |
| IO FiX | 118-50130 | FDA UDI | Class II | Active |
| Jones Screw | 142-45055 | FDA UDI | Class II | Active |
| Axis Plate | 148-10020 | FDA UDI | Class II | Active |
| IO FiX | 118-30024 | FDA UDI | Class II | Active |
| IO FiX | 118-40132 | FDA UDI | Class II | Active |
| IO Freedom | 118-45234 | FDA UDI | Class II | Active |
| Axis | 130-65075 | FDA UDI | Class II | Active |
| IO FiX | 118-50036 | FDA UDI | Class II | Active |
| Axis | 130-45925 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Extremity Medical, LLC has four FDA recall records initiated between April 13, 2011, and January 10, 2013, all marked as terminated. The reasons cited include discrepancies in lag screw measurements due to device calibration, a broken reamer during surgery without pre-drilling, lag screws passing through washers intra-operatively, and undersized guidewires affecting depth gauge accuracy for screw length selection.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 10, 2013 | Z-0952-2013 | — | terminated | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended. |
| Mar 22, 2012 | Z-0752-2013 | — | terminated | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected). |
| Apr 25, 2011 | Z-0438-2013 | — | terminated | Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. |
| Apr 13, 2011 | Z-0344-2013 | — | terminated | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. |