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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 21 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1743-3664-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 2832-1004 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3618-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5238-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-2028-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4062-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 2834-2002 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5272-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-2501 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6741-4400-N | FDA UDI | Class II | Active |
| Kinos Axiom | 2831.0113 | FDA UDI | Class II | Unknown |
| Ossera™ AFX | 1740-4068-N | FDA UDI | Class II | Active |
| Kinos Axiom | 2801.1002 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4240-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-7412 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3038-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3128-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4644-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4044-N | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-16131107 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4134-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4240-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-0900 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4268-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3858-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3126-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4274-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-4156-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3636-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4472-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4460-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5246-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3668-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4024-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3664-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4034-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5060-N | FDA UDI | Class II | Active |
| restor3d Kinos Axiom PSR | 5831-9003 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1214 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3466-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3122-N | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2719140505L | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6100-NSP-B0405 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6740-4430-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 1834-0041 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3636-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3130-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1058-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3848-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4640-N | FDA UDI | Class II | Active |
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