510(k) K002644
K002644 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "RADIAL HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on November 20, 2000. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2000
- Date Received
- August 24, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3170
- Review Panel
- OR
- Submission Type