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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 23 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1744-5218-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrumentation | 5113-B2002 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2723100505R | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4060-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-L1412 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1742-4070-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3016-N | FDA UDI | Class II | Active |
| restor3d Reusable Trial | 5000-0301 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1741-4600-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1072-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3166-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3640-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4074-N | FDA UDI | Class II | Active |
| Kinos Axiom | 2801.2004 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5046-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1110 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1114 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3162-N | FDA UDI | Class II | Active |
| Kinos Aeros Instrumentation | 5871-1156 | FDA UDI | Class II | Active |
| restor3d Reusable Instrument Tray | 5000-0401 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1740-3450-N | FDA UDI | Class II | Active |
| Veritas rTSA | 1506-1005 | FDA UDI | Class II | Active |
| Kinos Axiom | 5801.0002 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1064-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3438-N | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-L1418 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3438-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4126-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3636-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5266-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4452-N | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-132U3 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-14111100 | FDA UDI | Class I | Active |
| restor3d Total Talus Replacement | 1102-13 | FDA UDI | Unclassified | Active |
| Kinos Total Ankle Replacement | 3832-2210 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3452-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4062-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4454-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-9002 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1212 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2723100005R | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-2036-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-2124 | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2207 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-2110 | FDA UDI | Class II | Active |
| SafeView | 5801.4602 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6740-3426-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4446-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-9820 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5056-N | FDA UDI | Class II | Active |
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