BALANCE HIP SYSTEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Balance Hip System.

Pre-market Notification Details

• Device ID: K050251
• 510k Number: K050251
• Device Name: BALANCE HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Gary Baker
• Correspondent: Gary Baker; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: JDL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: LZY
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-03
• Decision Date: 2005-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304455474	K050251	000
00880304446458	K050251	000
00880304446441	K050251	000
00880304446434	K050251	000
00880304446427	K050251	000
00880304446410	K050251	000
00880304446403	K050251	000
00880304446397	K050251	000
00880304446380	K050251	000
00880304446373	K050251	000
00880304446366	K050251	000
00880304446359	K050251	000
00880304446342	K050251	000
00880304446465	K050251	000
00880304446472	K050251	000
00880304455467	K050251	000
00880304455450	K050251	000
00880304455443	K050251	000
00880304455436	K050251	000
00880304455429	K050251	000
00880304455412	K050251	000
00880304455405	K050251	000
00880304455399	K050251	000
00880304455382	K050251	000
00880304455375	K050251	000
00880304455368	K050251	000
00880304446489	K050251	000
00880304446335	K050251	000