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— 510(k) K193580
Substantially EquivalentOrthosensor, Inc.
FDA 510(k) clearance K193580 for 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, Substantially Equivalent on 2020-04-01. Applicant: Orthosensor, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthosensor, Inc.
- Product code
- Code ONN
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dania Beach, FL, US
Recent devices under product code ONN
view allMore clearances from Orthosensor, Inc.
view all- 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
- K180459 — VERASENSE for Zimmer Biomet Persona
- K150372 — VERASENSE Knee System
- K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.