ASCENSION PYROCARBON LUNATE— 510(k) K080997
Substantially EquivalentAscension Orthopedics, Inc.
FDA 510(k) clearance K080997 for ASCENSION PYROCARBON LUNATE, Substantially Equivalent on 2008-06-17. Applicant: Ascension Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedics, Inc.
- Product code
- Code KWN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3750
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWN
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