510(k) K082231
K082231 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION SILICONE PIP". The FDA issued a decision of Substantially Equivalent on January 12, 2009. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2009
- Date Received
- August 7, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Finger, Constrained, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3230
- Review Panel
- OR
- Submission Type