510(k) K051975

POROUS COATED DISCOVERY ELBOW by Biomet, Inc. — Product Code JDC

K051975 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "POROUS COATED DISCOVERY ELBOW". The FDA issued a decision of Substantially Equivalent on September 6, 2005. 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
September 6, 2005
Date Received
July 21, 2005
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