510(k) K931194

CO-CR ANSWER FEMORAL COMPONENT by Biomet, Inc. — Product Code JDG

K931194 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "CO-CR ANSWER FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on May 5, 1994. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Biomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1994
Date Received
March 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type