100KGY E-POLY MAXROM ACETABULAR LINERS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 100kgy E-poly Maxrom Acetabular Liners.

Pre-market Notification Details

• Device ID: K070364
• 510k Number: K070364
• Device Name: 100KGY E-POLY MAXROM ACETABULAR LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Tracy Bickel Johnson
• Correspondent: Tracy Bickel Johnson; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDI
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: MAY
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-07
• Decision Date: 2007-05-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304647688	K070364	000
00880304459762	K070364	000
00880304459755	K070364	000
00880304459731	K070364	000
00880304457539	K070364	000
00880304457478	K070364	000
00880304457461	K070364	000
00880304457454	K070364	000
00880304457034	K070364	000
00880304451674	K070364	000
00880304451667	K070364	000
00880304451643	K070364	000
00880304451612	K070364	000
00880304451605	K070364	000
00880304459779	K070364	000
00880304459793	K070364	000
00880304459809	K070364	000
00880304647671	K070364	000
00880304647572	K070364	000
00880304647565	K070364	000
00880304647558	K070364	000
00880304647541	K070364	000
00880304647534	K070364	000
00880304530836	K070364	000
00880304480834	K070364	000
00880304464094	K070364	000
00880304464063	K070364	000
00880304464049	K070364	000
00880304462502	K070364	000
00880304459823	K070364	000
00880304451544	K070364	000