Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
FDA 510(k) clearance K111779 · decided 2011-08-08
Clearance details
- K-number
- K111779
- Device name
- Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- Applicant
- Conmed Linvatec
- Decision
- Substantially Equivalent
- Date received
- 2011-06-24
- Decision date
- 2011-08-08
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.