BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
FDA 510(k) clearance K932925 · decided 1994-04-26
Clearance details
- K-number
- K932925
- Device name
- BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
- Applicant
- Vesitec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-15
- Decision date
- 1994-04-26
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use on recall (Z-1308-06) | Boston Scientific Corp | 2006-08-02 |
| Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. recall (Z-1309-06) | Boston Scientific Corp | 2006-08-02 |