TOGGLELOC SYSTEM
FDA 510(k) clearance K083070 · decided 2008-12-16
Clearance details
- K-number
- K083070
- Device name
- TOGGLELOC SYSTEM
- Applicant
- Biomet Sports Medicine
- Decision
- Substantially Equivalent
- Date received
- 2008-10-15
- Decision date
- 2008-12-16
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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