510(k) K162237
- Device
- XO1 Knee Balancing System
- Applicant
- XPANDORTHO, INC.
- 510(k) number
- K162237
- Product code
- ONN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-25
- Date received
- 2016-08-09
- Regulation
- 882.4560
- Classification name
- Intraoperative Orthopedic Joint Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- REBECCA K PINE
- Address
- 2223 Avenida De La Playa Suite 203 La Jolla CA US 92037 92037
FDA Registration Numbers#
- 3004180226
- 1721676
- 3004530184
- 3013756293
- 3033434191
- 9617840
- 3007521480
- 3005180920
- 3008110533
- 3015516266
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ONN #
| 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 Biomet Persona CR G-H/7-12 Left | Orthosensor, Inc. | 2020-04-01 |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018-06-07 |
| 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 |
Legacy Summary#
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FDA Review#
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