TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
FDA 510(k) clearance K090953 · decided 2010-01-21
Clearance details
- K-number
- K090953
- Device name
- TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
- Applicant
- Praxim Medivision, SA
- Decision
- Substantially Equivalent
- Date received
- 2009-04-03
- Decision date
- 2010-01-21
- Days to decision
- 293 days
- Clearance type
- Special
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- La Tronche, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iB recall (Z-0610-2017) | OMNI LIFE SCIENCE | 2016-11-17 |