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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4001 NC Hwy 54, Suite 2160, Durham, NC, 27709
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014833750
- DUNS Number
- —
Catalogue (2760)
Page 7 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX Instrumentation | 6744-3054-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1014-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3656-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5124-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4466-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Instrumentation | 5801-4074 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4254-N | FDA UDI | Class II | Active |
| Kinos Aeros Total Ankle Replacement | 1832-0051 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1038 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4262-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4060-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-9822 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3662-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-4034 | FDA UDI | Class II | Active |
| restor3d Reusable Trial | 5000-0201 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6744-5052-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3142-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-2058-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3862-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2113 | FDA UDI | Class II | Active |
| Kinos Total Ankle Instrumentation | 5801-4073 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-9813 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1007 | FDA UDI | Class II | Active |
| restor3d Lumbar Instrumentation | 5113-B6001 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3434-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-9811 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4660-N | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1101-18161018 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4260-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5170-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-2021 | FDA UDI | Class II | Active |
| Kinos Axiom | 3801-1112 | FDA UDI | Class II | Active |
| restor3d Lumbar Instrumentation | 5113-B0011 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5252-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3634-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1004 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-8306 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4646-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 2832-2003 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1110 | FDA UDI | Class II | Active |
| restor3d, Disposable Instrument, Cervical Cage Trial | 6110-001-17150707 | FDA UDI | Class I | Active |
| restor3d Lumbar Instrumentation | 5113-B4011 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1046-N | FDA UDI | Class II | Active |
| Kinos Axiom | 5801.0007 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3040-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3652-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3036-N | FDA UDI | Class II | Active |
| Kinos Aeros Instrumentation | 5871-4001 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4054-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5226-N | FDA UDI | Class II | Active |
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