510(k) K033930
K033930 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "KAPP CUSTOM ULNAR HEAD WRIST IMPLANT". The FDA issued a decision of Substantially Equivalent on July 28, 2004. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2004
- Date Received
- December 18, 2003
- Clearance Type
- Traditional
- 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