TRIBONE 80
FDA 510(k) clearance K071121 · decided 2007-09-11
Clearance details
- K-number
- K071121
- Device name
- TRIBONE 80
- Applicant
- Biomatlante
- Decision
- Substantially Equivalent
- Date received
- 2007-04-20
- Decision date
- 2007-09-11
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vigneux De Bretagne, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.