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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4001 NC Hwy 54, Suite 2160, Durham, NC, 27709
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014833750
- DUNS Number
- —
Catalogue (2760)
Page 33 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1740-4614-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3654-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4668-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3134-N | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-532C3 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4054-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2413 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4250-N | FDA UDI | Class II | Active |
| restor3d Kinos Axiom Total Ankle System | 1831.2110 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-002-22140707 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-002-22140907 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1140 | FDA UDI | Class II | Active |
| Kinos Axiom | 3801-1406 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4446-N | FDA UDI | Class II | Active |
| Kinos Aeros Instrumentation | 5871-9812 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5040-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 1834-0151 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-7007 | FDA UDI | Class II | Active |
| Kinos Axiom | 2801.1001 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4262-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3474-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-16130800 | FDA UDI | Class I | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-16131200 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1743-3644-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3670-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-9200 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3018-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-M1415 | FDA UDI | Class I | Active |
| restor3d Disposable Instrument, Wedge Trial | 6101-22200818 | FDA UDI | Class I | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-16130907 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1742-4474-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4444-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4230-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3666-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3028-N | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2723140505L | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-9012 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4150-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3822-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3026-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3866-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4666-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-A0026 | FDA UDI | Class I | Active |
| Kinos Axiom | 3801-1110 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4272-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4244-N | FDA UDI | Class II | Active |
| Veritas rTSA | 1501-3604 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5038-N | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-532C1 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-002-18120616 | FDA UDI | Class II | Active |
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