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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 48 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX Instrumentation | 6742-3438-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3874-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3640-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4034-N | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-S1618 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3436-N | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-M1015 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4134-N | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1101-010-202008 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3432-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 2832-1003 | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-A1002 | FDA UDI | Class I | Active |
| Kinos Axiom Instrumentation | 5801-8208 | FDA UDI | Class II | Active |
| restor3d Kinos Axiom Total Ankle System | 1831.2130 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-2020-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4264-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4158-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6741-4201-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4462-N | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-1073 | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-536C3 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4216-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4026-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4432-N | FDA UDI | Class II | Active |
| restor3d Lumbar Instrumentation | 5113-B0001 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5066-N | FDA UDI | Class II | Active |
| restor3d Anatomic Bone Model | 6000-1000 | FDA UDI | Class I | Active |
| restor3d Utility Wedge | 1105-2723140505R | FDA UDI | Class II | Active |
| restor3d Kinos Axiom Total Ankle System | 1831.2131 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3850-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-4024-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1740-3830-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5248-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1742-3440-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-3866-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3056-N | FDA UDI | Class II | Active |
| Kinos Aeros Total Ankle Replacement | 5871-1057 | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2412 | FDA UDI | Class II | Active |
| Veritas rTSA | 1505-4842 | FDA UDI | Class II | Active |
| restor3d, Disposable Instrument, Cervical Cage Trial | 6110-001-16131007 | FDA UDI | Class I | Active |
| Veritas rTSA | 1501-4001 | FDA UDI | Class II | Active |
| restor3d Utility Wedge | 1101-010-181806 | FDA UDI | Class II | Active |
| Veritas rTSA | 3500-336C1 | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-1407 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5136-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5024-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 3832-2411 | FDA UDI | Class II | Active |
| restor3d Osteotomy Wedge | 1100-001-16140407 | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-3164-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-1401 | FDA UDI | Class II | Active |
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