STRYKER WEDGE SUTURE ANCHOR
FDA 510(k) clearance K983557 · decided 1998-12-18
Clearance details
- K-number
- K983557
- Device name
- STRYKER WEDGE SUTURE ANCHOR
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1998-10-13
- Decision date
- 1998-12-18
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intende recall (Z-1537-2008) | Stryker Endoscopy | 2008-08-06 |
| Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended recall (Z-1538-2008) | Stryker Endoscopy | 2008-08-06 |