RX90 FEMORAL COMPONENT

Prosthesis, Hip, Femoral Component, Cemented, Metal

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Rx90 Femoral Component.

Pre-market Notification Details

• Device ID: K942028
• 510k Number: K942028
• Device Name: RX90 FEMORAL COMPONENT
• Classification: Prosthesis, Hip, Femoral Component, Cemented, Metal
• Applicant: BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia S Beres
• Correspondent: Patricia S Beres; BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDG
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-26
• Decision Date: 1994-09-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304257283	K942028	000
00880304226050	K942028	000
00880304226043	K942028	000
00880304226036	K942028	000
00880304226029	K942028	000
00880304226012	K942028	000
00880304225992	K942028	000
00880304225985	K942028	000
00880304225961	K942028	000
00880304008397	K942028	000
00880304007666	K942028	000
00880304001152	K942028	000
00887868163517	K942028	000
00887868163500	K942028	000
00887868163494	K942028	000
00887868163487	K942028	000
00887868163470	K942028	000
00880304226067	K942028	000
00880304226074	K942028	000
00880304257276	K942028	000
00880304257269	K942028	000
00880304257252	K942028	000
00880304257245	K942028	000
00880304236905	K942028	000
00880304236899	K942028	000
00880304236875	K942028	000
00880304236851	K942028	000
00880304236844	K942028	000
00880304236790	K942028	000
00880304236769	K942028	000
00880304226142	K942028	000
00880304226135	K942028	000
00880304226128	K942028	000
00880304226104	K942028	000
00880304226098	K942028	000
00880304873810	K942028	000