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Sign in to claim this brandExtremity Medical, LLC
United States·US-MF-000018334
Last updated September 17, 2026
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 2 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IO FiX | 118-50140 | FDA UDI | Class II | Active |
| Axis | 130-85135 | FDA UDI | Class II | Active |
| Xmcp | 120-32530 | FDA UDI | Class II | Active |
| IO FiX | 118-40438 | FDA UDI | Class II | Active |
| Omni Stable AF | 144-10252 | FDA UDI | Class II | Active |
| Omni | 144-20040 | FDA UDI | Class II | Active |
| Axis Plate | 148-45120 | FDA UDI | Class II | Active |
| IO FiX | 118-40432 | FDA UDI | Class II | Active |
| Axis | 130-75055 | FDA UDI | Class II | Active |
| Omni | 144-35236 | FDA UDI | Class II | Active |
| CompressX | 101-45052-2 | FDA UDI | Class II | Active |
| IO Freedom | 136-65245 | FDA UDI | Class II | Active |
| Omni Stable AF | 144-28046 | FDA UDI | Class II | Active |
| Axis Plate | 148-35045 | FDA UDI | Class II | Active |
| IO FiX | 118-40428 | FDA UDI | Class II | Active |
| IO FiX | 118-40436 | FDA UDI | Class II | Active |
| IO FiX | 118-30438 | FDA UDI | Class II | Active |
| IO Freedom | 136-65250 | FDA UDI | Class II | Active |
| Omni Mini | 154-35120 | FDA UDI | Class II | Active |
| Axis Plate | 148-35160 | FDA UDI | Class II | Active |
| Axis Plate | 148-52125 | FDA UDI | Class II | Active |
| CarpalFiX | 127-46712 | FDA UDI | Class II | Active |
| ApeX | 121-44520 | FDA UDI | Class II | Active |
| Axis | 130-65095 | FDA UDI | Class II | Active |
| IO FiX | 118-65140 | FDA UDI | Class II | Active |
| KinematX | 137-30201-S | FDA UDI | Class II | Active |
| Omni Stable AF | 144-35056 | FDA UDI | Class II | Active |
| Axis | 130-85170 | FDA UDI | Class II | Active |
| CarpalFiX | 127-46610-SW | FDA UDI | Class II | Active |
| IO FiX | 118-40340 | FDA UDI | Class II | Active |
| IO FiX | 118-50025 | FDA UDI | Class II | Active |
| IO FiX | 118-30118 | FDA UDI | Class II | Active |
| Omni Mini | 154-28034 | FDA UDI | Class II | Active |
| Omni Mini | 154-28018 | FDA UDI | Class II | Active |
| Omni Stable AF | 144-35058 | FDA UDI | Class II | Active |
| IO FiX | 118-65080 | FDA UDI | Class II | Active |
| Axis Plate | 148-30009 | FDA UDI | Class II | Active |
| Axis Plate | 148-35030 | FDA UDI | Class II | Active |
| IO FiX | 118-50035 | FDA UDI | Class II | Active |
| AlignX | 136-40136 | FDA UDI | Class II | Active |
| Axis Plate | 148-40022 | FDA UDI | Class II | Active |
| IO Freedom | 147-35226 | FDA UDI | Class II | Active |
| ApeX | 121-00000 | FDA UDI | Class I | Active |
| IO FiX | 118-30420 | FDA UDI | Class II | Active |
| Axis | 130-45060 | FDA UDI | Class II | Active |
| AlignX | 136-65165 | FDA UDI | Class II | Active |
| Xmcp | 120-22530 | FDA UDI | Class II | Active |
| Omni Stable AF | 155-25500 | FDA UDI | Class II | Active |
| IO FiX | 118-30226 | FDA UDI | Class II | Active |
| CompressX | 101-65030-2 | 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.
| 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. |