Intraoperative Orthopedic Joint Assessment Aid
Regulation 882.4560
2510(k)s in 12 months (18 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in ONN
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthosensor, Inc. | 8 | 8 |
| Orthalign, Inc. | 3 | 0 |
| Eventum Orthopaedics, Ltd. | 2 | 0 |
| Synvasive Technology, Inc. | 2 | 0 |
| Kamm & Associates | 1 | 0 |
| These Three Medical, LLC | 1 | 0 |
| Xpandortho, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R. Terminated |
ONN | K180459 |
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L. Terminated |
ONN | K180459 |
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R. Terminated |
ONN | K180459 |
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L. Terminated |
ONN | K180459 |
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R. Terminated |
ONN | K180459 |
| Jul 12, 2018 | Orthosensor, Inc. OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L. Terminated |
ONN | K180459 |
| Jan 29, 2015 | Orthosensor, Inc. Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery. Terminated |
ONN | K130380 |
| Oct 24, 2012 | Orthosensor "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***"
Rx Only*** Sterile/EO***Made exclusively for Stryker Orth Terminated |
ONN | None listed |
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