510(k) K090473
K090473 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "DISCOVERY ELBOW - X-SMALL". The FDA issued a decision of Substantially Equivalent on March 25, 2009. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2009
- Date Received
- February 24, 2009
- Clearance Type
- Special
- 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