Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
FDA 510(k) clearance K150648 · decided 2015-08-20
Clearance details
- K-number
- K150648
- Device name
- Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
- Applicant
- Arthrex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-12
- Decision date
- 2015-08-20
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.