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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 14 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1744-4052-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4664-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3824-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4034-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3874-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3124-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5114-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4272-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1210 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4642-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1044-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-M1618 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1742-4040-N | FDA UDI | Class II | Active |
| Kinos Aeros Instrumentation | 5871-9814 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3448-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-9824 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2719120505R | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4260-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4264-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3640-N | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-16130507 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-002-22140507 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-1016-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-4061 | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-132U1 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-002-22140613 | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 2834-1003 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2719100005R | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6101-18161218 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1744-4038-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument Kit | 4110-S023 | FDA UDI | Class I | Active |
| Kinos Axiom | 1801.1130 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1105-2723120005L | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6100-001-20140507 | FDA UDI | Class I | Active |
| restor3d Cervical Cage | 1110-17151000 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4446-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2310 | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-M1212 | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-17150507 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-001-16140507 | FDA UDI | Class II | Active |
| restor3d, Disposable Instrument, Cervical Cage Trial | 6110-001-17151207 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6742-4462-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-S1215 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1740-4432-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4256-N | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-16130607 | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 2832-2002 | FDA UDI | Class II | Active |
| Kinos Axiom | 2831.0213 | FDA UDI | Class II | Unknown |
| Kinos Aeros Total Ankle Replacement | 1833-0104 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1074-N | FDA UDI | Class II | Active |
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