SWANSON TITANIUM CARPAL LUNATE IMPLANT
FDA 510(k) clearance K864491 · decided 1987-04-15
Clearance details
- K-number
- K864491
- Device name
- SWANSON TITANIUM CARPAL LUNATE 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
- KWN
- Device class
- 2
- Regulation number
- 888.3750
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Wrist Hemiarthroplasty System (K141920) | Arthrosurface, Inc. | 2014-12-23 |
| ASCENSION PYROCARBON LUNATE (K080997) | Ascension Orthopedics, Inc. | 2008-06-17 |
| MAESTRO CARPAL HEMIARTHROPLASTY (K050028) | Biomet Manufacturing, Inc. | 2005-03-25 |
| AMC R METACARPAL COMPONENT (K790793) | Howmedica Corp. | 1979-06-22 |
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 |