OSTEORAPTOR SUTURE ANCHOR
FDA 510(k) clearance K082215 · decided 2008-11-03
Clearance details
- K-number
- K082215
- Device name
- OSTEORAPTOR SUTURE ANCHOR
- Applicant
- Smith & Nephew Inc., Endoscopy Division
- Decision
- Substantially Equivalent
- Date received
- 2008-08-06
- Decision date
- 2008-11-03
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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