510(k) K990596
K990596 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 1999. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1999
- Date Received
- February 24, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type