Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOrthalign, Inc.
United States·US-MF-000027362
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 153, Technology, Irvine, United States
- Website
- www.orthalign.com
- —
- —
- [email protected]
- Phone
- 949.715.2424
- PRRC Contact
- Karyl Haskell
- EUDAMED SRN
- US-MF-000027362
- FDA FEI Number
- 3007521480
- DUNS Number
- 023266163
Catalogue (373)
Page 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OrthAlign Plus | 403203 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403430-02 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant | 402528-05 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403242 | FDA UDI | Class II | Active |
| OrthAlign Plus | 401646 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403055 | FDA UDI | Class II | Active |
| Lantern | 405251 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403494-090 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403375 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403221 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403007-03 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403483 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403321 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant (LSA) | KA406000-02 | FDA UDI | Class II | Active |
| KneeAlign 2 | 401548 | FDA UDI | Class II | Active |
| KneeAlign 2 | 402104 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403412 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant (LSA) | 406000-01 | FDA UDI | Class II | Active |
| OrthAlign Plus | 402162 | FDA UDI | Class II | Active |
| Harvey Surgical Assistant (HSA) | 405055 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403008-03 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant | 402507 | FDA UDI | Class II | Active |
| KneeAlign 2 | 402064-09 | FDA UDI | Class II | Active |
| Lantern | 403545 | FDA UDI | Class II | Active |
| Lantern | 405314 | FDA UDI | Class II | Active |
| OrthAlign Plus | 401760 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403424 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403343 | FDA UDI | Class II | Active |
| KneeAlign 2 | 401576 | FDA UDI | Class II | Active |
| Harvey Surgical Assistant (HSA) | 405080 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant (LSA) | 401788 | FDA UDI | Class II | Active |
| OrthAlign Plus | 401777 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant | 402528-06 | FDA UDI | Class II | Active |
| KneeAlign 2 | 402098 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403007-21 | FDA UDI | Class II | Active |
| KneeAlign 2 | 401285 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403305 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403001 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403007-19 | FDA UDI | Class II | Active |
| OrthAlign Plus | 402150 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403426 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403468 | FDA UDI | Class II | Active |
| Lantern | 403591 | FDA UDI | Class II | Active |
| OrthAlign Plus | 401749 | FDA UDI | Class II | Active |
| Harvey Surgical Assistant (HSA) | 405062 | FDA UDI | Class II | Active |
| Harvey Surgical Assistant (HSA) | 405081 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403478 | FDA UDI | Class II | Active |
| OrthAlign Plus | 402099 | FDA UDI | Class II | Active |
| OrthAlign Plus | 403008-02 | FDA UDI | Class II | Active |
| Lantern Surgical Assistant (LSA) | 402477 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 10, 2026 | Z-1630-2026 | — | open, classified | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| Feb 10, 2026 | Z-1629-2026 | — | open, classified | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |