SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
FDA 510(k) clearance K864490 · decided 1987-04-15
Clearance details
- K-number
- K864490
- Device name
- SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1986-11-13
- Decision date
- 1987-04-15
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- KWO
- Device class
- 2
- Regulation number
- 888.3760
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |