510(k) K983036
K983036 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "SINGLE AXLE TOTAL ELBOW". The FDA issued a decision of Substantially Equivalent on April 30, 1999. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1999
- Date Received
- August 31, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Constrained, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3150
- Review Panel
- OR
- Submission Type