NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
FDA 510(k) clearance K041369 · decided 2004-06-22
Clearance details
- K-number
- K041369
- Device name
- NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
- Applicant
- Orthosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-24
- Decision date
- 2004-06-22
- Days to decision
- 29 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 |
|---|---|---|
| Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smi recall (Z-2444-2008) | Zimmer Inc. | 2008-09-23 |