BIORAPTOR 2.3 PK SUTURE ANCHOR
FDA 510(k) clearance K071586 · decided 2007-08-17
Clearance details
- K-number
- K071586
- Device name
- BIORAPTOR 2.3 PK SUTURE ANCHOR
- Applicant
- Smith & Nephew Inc., Endoscopy Division
- Decision
- Substantially Equivalent
- Date received
- 2007-06-11
- Decision date
- 2007-08-17
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. recall (Z-0581-2025) | Smith & Nephew Inc. | 2024-11-29 |