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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
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- FDA FEI Number
- 3014833750
- DUNS Number
- —
Catalogue (2760)
Page 55 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ossera™ AFX | 1744-4164-N | FDA UDI | Class II | Active |
| restor3d Lumbar Implant | 1113-L1615 | FDA UDI | Class II | Active |
| Kinos Axiom Instrumentation | 5801-7308 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-3636-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-5226-N | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-1701 | FDA UDI | Class II | Active |
| restor3d Veritas rTSA Instrumentation | 5500-2201 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3630-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3654-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-4126-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-3660-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-5140-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3670-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4022-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4418-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1056-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4466-N | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-001-17151107 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6741-4200-N | FDA UDI | Class II | Active |
| Kinos Total Ankle Replacement | 2833-1001 | FDA UDI | Class II | Active |
| restor3d Cervical Cage | 1110-16130600 | FDA UDI | Class II | Active |
| restor3d Lumbar Instrument | 5113-L1012 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6740-4628-N | FDA UDI | Class II | Active |
| restor3d Reusable Instrument Tray/Kit | 5000-0401K | FDA UDI | Class I | Active |
| Kinos Total Ankle Replacement | 3832-2211 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-14110807 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6742-3638-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3064-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-4246-N | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Wedge Trial | 6101-009-20180818 | FDA UDI | Class I | Active |
| Ossera™ AFX Instrumentation | 6744-5126-N | FDA UDI | Class II | Active |
| Kinos Axiom Total Ankle Replacement | 2832-2004 | FDA UDI | Class II | Active |
| restor3d Disposable Instrument, Cervical Cage Trial | 6110-16131207 | FDA UDI | Class I | Active |
| Ossera™ AFX | 1740-4658-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1743-4464-N | FDA UDI | Class II | Active |
| Ossera™ AFX | 1744-1050-N | FDA UDI | Class II | Active |
| Kinos Instrumentation | 5801-1124 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6742-4052-N | FDA UDI | Class II | Active |
| Veritas rTSA | 1504-4850 | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6740-3830-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6744-3036-N | FDA UDI | Class II | Active |
| Ossera™ AFX Instrumentation | 6743-4272-N | FDA UDI | Class II | Active |
| Veritas Reverse Total Shoulder System | K253992 | FDA 510(k) | Class II | Active |
| restor3d Pin Implants | K211789 | FDA 510(k) | Class II | Active |
| restor3d TIDAL Lumbar Interbody Fusion System | K234087 | FDA 510(k) | Class II | Active |
| restor3d Reverse Total Shoulder Arthroplasty System | K243643 | FDA 510(k) | Class II | Active |
| Kinos Total Ankle System | K242868 | FDA 510(k) | Class II | Active |
| Kinos Total Ankle System | K241482 | FDA 510(k) | Class II | Active |
| TIDAL Fusion Cage System | K242356 | FDA 510(k) | Class II | Active |
| Restor3d Utility Wedge | K201314 | FDA 510(k) | Class II | Active |
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