510(k) K982268
K982268 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "ULNAR HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1998
- Date Received
- June 29, 1998
- 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