Company ยท US
Orthosensor, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2020. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 16 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2020 | K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MI Orthosensor, Inc. | ONN |
| Apr 12, 2020 | K200665 | VERASENSE for Stryker Triathlon Orthosensor, Inc. | ONN |
| Apr 1, 2020 | 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 Orthosensor, Inc. | ONN |
| Jun 7, 2018 | K180459 | VERASENSE for Zimmer Biomet Persona Orthosensor, Inc. | ONN |
| Apr 15, 2016 | K150372 | VERASENSE Knee System Orthosensor, Inc. | ONN |
| Nov 8, 2013 | K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM Orthosensor, Inc. | ONN |
| Jun 13, 2013 | K130380 | ORTHOSENSOR KNEE BALANCER Orthosensor, Inc. | ONN |
| Oct 19, 2009 | K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR Orthosensor, Inc. | ONN |
Latest recalls
| 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 |