510(k) K053119
K053119 is an FDA 510(k) premarket notification submitted by Aptis Medical, LLC for the device "DISTAL RADIO-ULNAR JOINT IMPLANT". The FDA issued a decision of Substantially Equivalent on December 7, 2005. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Aptis Medical, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2005
- Date Received
- November 7, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Hemi-, Ulnar
- Device Class
- Class II
- Regulation Number
- 888.3810
- Review Panel
- OR
- Submission Type