SPIRALOK ANCHOR
FDA 510(k) clearance K060271 · decided 2006-05-04
Clearance details
- K-number
- K060271
- Device name
- SPIRALOK ANCHOR
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2006-02-01
- Decision date
- 2006-05-04
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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