Product code ONN
- Device name
- Intraoperative Orthopedic Joint Assessment Aid
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Measurement and interpretation of orthopedic joint information.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | 2025-09-09 |
| K241298 | QUADSENSE | Eventum Orthopaedics, Ltd. | 2024-10-04 |
| K242616 | Lantern® Hip | Orthalign, Inc. | 2024-10-03 |
| K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022-09-15 |
| 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 |
| K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | 2020-04-12 |
| 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 ... | Orthosensor, Inc. | 2020-04-01 |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018-06-07 |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | 2017-04-25 |
| K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016-04-15 |
| K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR | Kamm & Associates | 2014-03-21 |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Orthosensor, Inc. | 2013-11-08 |
| K130380 | ORTHOSENSOR KNEE BALANCER | Orthosensor, Inc. | 2013-06-13 |
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Synvasive Technology, Inc. | 2011-03-22 |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | 2009-10-19 |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Synvasive Technology, Inc. | 2007-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810832032328 | Lantern | Orthalign, Inc. | 2025-12-29 |
| 00810832032489 | Lantern | Orthalign, Inc. | 2025-12-12 |
| 00810832032243 | Lantern | Orthalign, Inc. | 2025-11-19 |
| 00810832031994 | Lantern | Orthalign, Inc. | 2025-09-12 |
| 00810832032311 | Lantern | Orthalign, Inc. | 2025-05-06 |
| 00810832032335 | Lantern | Orthalign, Inc. | 2025-05-06 |
| 00810832032229 | Lantern | Orthalign, Inc. | 2025-04-24 |
| 05065012584493 | Quadsense Pro | EVENTUM ORTHOPAEDICS LTD | 2025-04-04 |
| 05065012584516 | Panel PC | EVENTUM ORTHOPAEDICS LTD | 2025-01-22 |
| 05065012584523 | Trolly | EVENTUM ORTHOPAEDICS LTD | 2025-01-22 |
| 05065012584233 | Dongle Assembly | EVENTUM ORTHOPAEDICS LTD | 2025-01-22 |
| 05065012584158 | Quadsense | EVENTUM ORTHOPAEDICS LTD | 2025-01-22 |
| 00810832032199 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032168 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032151 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032144 | Lantern Surgical Assistant | Orthalign, Inc. | 2024-12-13 |
| 00810832032137 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032120 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032106 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032076 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032069 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032045 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032038 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032021 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832032014 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832031932 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832031925 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832031918 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832031901 | Lantern | Orthalign, Inc. | 2024-12-13 |
| 00810832031895 | Lantern | Orthalign, Inc. | 2024-12-13 |