NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
FDA 510(k) clearance K030827 · decided 2003-05-23
Clearance details
- K-number
- K030827
- Device name
- NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
- Applicant
- Orthosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-14
- Decision date
- 2003-05-23
- Days to decision
- 70 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 |
|---|---|---|
| Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Cana recall (Z-2445-2008) | Zimmer Inc. | 2008-09-20 |