MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
FDA 510(k) clearance K070925 · decided 2007-05-02
Clearance details
- K-number
- K070925
- Device name
- MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2007-04-03
- Decision date
- 2007-05-02
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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