BIOKNOTLESS AND LUPINE PLUS ANCHORS
FDA 510(k) clearance K062170 · decided 2006-08-22
Clearance details
- K-number
- K062170
- Device name
- BIOKNOTLESS AND LUPINE PLUS ANCHORS
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2006-07-31
- Decision date
- 2006-08-22
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- JDR
- 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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