Orthosensor, Inc.
Orthosensor, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2020, with 7 FDA device recalls on record.
Top product codes for Orthosensor, Inc.
FDA recalls by Orthosensor, Inc.
- Z-0084-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
- Z-0085-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
- Z-0087-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
- Z-0086-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
- Z-0082-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
- Z-0083-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
- Z-1029-2015 — Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Orthosensor, Inc.
- 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
- K200665 — VERASENSE for Stryker Triathlon
- 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
- K180459 — VERASENSE for Zimmer Biomet Persona
- K150372 — VERASENSE Knee System
- K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
- K130380 — ORTHOSENSOR KNEE BALANCER
- K090474 — ORTHOREX INTRA-OPERATIVE LOAD SENSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.