Lantern
Lantern Hip, Navigation Unit, Supine and Lateral
1manufacturer
24catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Immetech Industrial Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | OrthAlign, Inc., United States |
|---|---|
| FDA product code | ONN |
| Device type | Intraoperative Orthopedic Joint Assessment Aid |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K242616 |
| Record published | 2024-12-13 |
| Record revised | 2025-12-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -22 to 140 °F; Handling environment temperature -22 to 140 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 403544 | In distribution | |
| 403545 | In distribution | |
| 403589 | In distribution | |
| 403577 | In distribution | |
| 403565 | In distribution | |
| 403551 | In distribution | |
| 405253 | In distribution | |
| 405250 | In distribution | |
| 403579 | In distribution | |
| 403599 | In distribution | |
| 502001-01 | In distribution | |
| 405251 | In distribution | |
| 403547 | In distribution | |
| 502000-01 | In distribution | |
| 403597 | In distribution | |
| 403591 | In distribution | |
| 403564 | In distribution | |
| 403567 | In distribution | |
| 403595 | In distribution | |
| 403543 | In distribution | |
| 403566 | In distribution | |
| 502000-02 | In distribution | |
| 403569 | In distribution | |
| 403568 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verasense | Orthosensor, Inc. | 140 |
| LinkStation Mini | Orthosensor, Inc. | 8 |
| Linkstation Mini Evaluation Kit | Orthosensor, Inc. | 8 |
| Verasense for Stryker Triathlon | Orthosensor, Inc. | 6 |
| Verasense for Zimmer Biomet Persona | Orthosensor, Inc. | 6 |
| Lantern ASC | OrthAlign, Inc. | 4 |
| eLIBRA® | Synvasive Technology, Inc. | 2 |
| Verasense for Exactech Equinoxe Reverse | Orthosensor, Inc. | 2 |
| Lantern Surgical Assistant | OrthAlign, Inc. | 1 |
| Dongle Assembly | Eventum Orthopaedics Ltd | 1 |
| Quadsense Pro | Eventum Orthopaedics Ltd | 1 |
| Trolly | Eventum Orthopaedics Ltd | 1 |
Showing 12 of 15. All products under Intraoperative Orthopedic Joint Assessment Aid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262253 | 2026-07-31 |
| K253507 | 2026-06-02 |
| K242616 | 2024-10-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.