NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
FDA 510(k) clearance K071929 · decided 2007-09-19
Clearance details
- K-number
- K071929
- Device name
- NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
- Applicant
- Orthosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-13
- Decision date
- 2007-09-19
- Days to decision
- 68 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| NDI P7 Position Sensor, Stereotaxic Instrument recall (Z-2048-2017) | Orthosoft, Inc. dba Zimmer CAS | 2017-05-08 |
| Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20- recall (Z-0558-2010) | Zimmer Inc. | 2009-12-22 |