FDA Product Code
FDA Product Code ONN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | 2026-07-31 | Special | PDF ↗ |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. | 2026-06-02 | Traditional | PDF ↗ |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | 2025-09-09 | Special | PDF ↗ |
| K241298 | QUADSENSE | Eventum Orthopaedics, Ltd. | 2024-10-04 | Traditional | PDF ↗ |
| K242616 | Lantern® Hip | Orthalign, Inc. | 2024-10-03 | Special | PDF ↗ |
| K220830 | TrueBalance Surgical System | These Three Medical, LLC | 2022-09-15 | Traditional | PDF ↗ |
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | Orthosensor, Inc. | 2020-08-25 | Traditional | PDF ↗ |
| K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | 2020-04-12 | Special | PDF ↗ |
| K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | Orthosensor, Inc. | 2020-04-01 | Traditional | PDF ↗ |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018-06-07 | Traditional | PDF ↗ |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | 2017-04-25 | Traditional | PDF ↗ |
| K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR | Kamm & Associates | 2014-03-21 | Special | PDF ↗ |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Orthosensor, Inc. | 2013-11-08 | Special | PDF ↗ |
| K130380 | ORTHOSENSOR KNEE BALANCER | Orthosensor, Inc. | 2013-06-13 | Special | PDF ↗ |
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Synvasive Technology, Inc. | 2011-03-22 | Traditional | PDF ↗ |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | 2009-10-19 | Traditional | PDF ↗ |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Synvasive Technology, Inc. | 2007-04-04 | Traditional | PDF ↗ |
Product code ONN · Class II · Neurology. Data: openFDA.