OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
FDA 510(k) clearance K090615 · decided 2009-06-03
Clearance details
- K-number
- K090615
- Device name
- OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-09
- Decision date
- 2009-06-03
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. recall (Z-1952-2011) | ArthroCare Corporation | 2011-04-12 |