510(k) K942028

RX90 FEMORAL COMPONENT by Biomet, Inc. — Product Code JDG

K942028 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "RX90 FEMORAL COMPONENT". The FDA issued a decision of SN on September 19, 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
SN ()
Decision Date
September 19, 1994
Date Received
April 26, 1994
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