NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
FDA 510(k) clearance K071714 · decided 2007-07-20
Clearance details
- K-number
- K071714
- Device name
- NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
- Applicant
- Orthosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-22
- Decision date
- 2007-07-20
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20- recall (Z-0558-2010) | Zimmer Inc. | 2009-12-22 |
| Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthope recall (Z-0985-2009) | Zimmer Inc. | 2009-03-02 |