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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 47 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| restor3d Veritas rTSA Instrumentation | 5500-3101 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-14110900 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6742-3840-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4468-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1224 | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-2902 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1034 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6100-001-16140507 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1740-4632-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4448-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3660-N | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-136C1 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3150-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3872-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3836-N | FDA UDI | Class II | Active |
| restor3d Kinos Axiom PSR | 5831-9005 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3470-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4116-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4128-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-14110700 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1744-5070-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4452-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1016-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3468-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3870-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 1834-0050 | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-14110500 | FDA UDI | Class II | Active |
| Kinos Axiom | 2801.2005 | FDA UDI | Class II | Unknown |
| restor3d Lumbar Instrument | 5113-A2001 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1740-3416-N | FDA UDI | Class II | Active |
| restor3d Total Talus Replacement | 1102-04 | FDA UDI | Unclassified | Active |
| restor3d Cervical Cage | 1110-17151007 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3146-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5224-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5871-2712 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1042 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6741-4001-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4422-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3846-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4252-N | FDA UDI | Class II | Active |
| Kinos Aeros Instrumentation | 5871-9815 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1101-010-202012 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5030-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1741-4000-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-14110707 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1743-4070-N | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-20140607 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4632-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 2833-2001 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4248-N | FDA UDI | Class II | Active |
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