Lantern Surgical Assistant
Adapter Clamp, Small 0.325”-0.500”
1manufacturer
1catalogue number
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 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 403578 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verasense | Orthosensor, Inc. | 140 |
| Lantern | OrthAlign, Inc. | 24 |
| 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 |
| 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.