GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
FDA 510(k) clearance K101557 · decided 2010-07-01
Clearance details
- K-number
- K101557
- Device name
- GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
- Applicant
- Etex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-04
- Decision date
- 2010-07-01
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.