ASCENSION PYROCARBON LUNATE
FDA 510(k) clearance K080997 · decided 2008-06-17
Clearance details
- K-number
- K080997
- Device name
- ASCENSION PYROCARBON LUNATE
- Applicant
- Ascension Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-08
- Decision date
- 2008-06-17
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KWN
- Device class
- 2
- Regulation number
- 888.3750
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Wrist Hemiarthroplasty System (K141920) | Arthrosurface, Inc. | 2014-12-23 |
| MAESTRO CARPAL HEMIARTHROPLASTY (K050028) | Biomet Manufacturing, Inc. | 2005-03-25 |
| SWANSON TITANIUM CARPAL LUNATE IMPLANT (K864491) | Dow Corning Wright | 1987-04-15 |
| AMC R METACARPAL COMPONENT (K790793) | Howmedica Corp. | 1979-06-22 |
Recalls involving this device
No recalls on record reference this clearance.