510(k) K080997
K080997 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION PYROCARBON LUNATE". The FDA issued a decision of Substantially Equivalent on June 17, 2008. The device falls under product code KWN (Prosthesis, Wrist, Carpal Lunate), a Class II device regulated under 21 CFR 888.3750. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2008
- Date Received
- April 8, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Carpal Lunate
- Device Class
- Class II
- Regulation Number
- 888.3750
- Review Panel
- OR
- Submission Type