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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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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014833750
- DUNS Number
- —
Catalogue (2760)
Page 32 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1740-3668-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-2050-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4228-N | FDA UDI | Class II | Active |
| Kinos Axiom | 3801-1308 | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-14111207 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3650-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4040-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5168-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3448-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4024-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3068-N | FDA UDI | Class II | Active |
| Kinos Axiom | 1801.1140 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4468-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3670-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3116-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4240-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1109 | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 1834-0040 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3050-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3872-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5238-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-N01-KTS01NST | FDA UDI | Class I | Active |
| Kinos Axiom Instrumentation | 5801-9814 | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1306 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-17151007 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6744-5050-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4240-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 1834-0031 | FDA UDI | Class II | Active |
| Kinos Axiom | 2801.2001 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1220 | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-2221 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3150-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5032-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4066-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3656-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-9815 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4666-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3640-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1223 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1062-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4170-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1216 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1051 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4450-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-4672-N | FDA UDI | Class II | Active |
| restor3d Total Talus Replacement | 6102-600 | FDA UDI | Unclassified | Active |
| restor3d Osteotomy Wedge | 1100-002-22141228 | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-3401 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-8212 | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-L1615 | FDA UDI | Class I | Active |
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