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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 35 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1743-3860-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4042-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3820-N | FDA UDI | Class II | Active |
| restor3d, Disposable Instrument, Cervical Cage | 6110-001-14110707 | FDA UDI | Class I | Active |
| Kinos Axiom | 1801.2150 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-2072-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5036-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4154-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3856-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1006 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-2062-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3872-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument | 4103-G | FDA UDI | Class I | Active |
| Kinos Total Ankle Replacement | 3832-2111 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4454-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6741-3401-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3424-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-S1415 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6742-3664-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3660-N | FDA UDI | Class II | Active |
| Veritas rTSA | 1504-4830 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5046-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3022-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-S1015 | FDA UDI | Class I | Active |
| restor3d Osteotomy Wedge | 1100-002-22140510 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4450-N | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-L1218 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1029 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4044-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1030-N-C01 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5256-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-9308 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1022-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-4101 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6101-009-18161018 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6744-4144-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 2834-1001 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4046-N | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-16130807 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-2040-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3674-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-9826 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-16130700 | FDA UDI | Class I | Active |
| restor3d Osteotomy Wedge | 1101-22201018 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-17150707 | FDA UDI | Class I | Active |
| Veritas rTSA | 3500-332U3 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-4063 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5248-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-9012 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5128-N | FDA UDI | Class II | Active |
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