BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831

Plate, Fixation, Bone

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Reconstructive Wedges Model 110003660-99, 110003797-831.

Pre-market Notification Details

• Device ID: K122770
• 510k Number: K122770
• Device Name: BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
• Classification: Plate, Fixation, Bone
• Applicant: BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-10
• Decision Date: 2013-03-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304928282	K122770	000
00887868106545	K122770	000
00887868106538	K122770	000
00887868106521	K122770	000
00887868106514	K122770	000
00887868106507	K122770	000
00887868106491	K122770	000
00887868106484	K122770	000
00887868106477	K122770	000
00887868106460	K122770	000
00887868106453	K122770	000
00887868106446	K122770	000
00887868106439	K122770	000
00887868106552	K122770	000
00887868106569	K122770	000
00880304840805	K122770	000
00880304562820	K122770	000
00887868106804	K122770	000
00887868106798	K122770	000
00887868106781	K122770	000
00887868130939	K122770	000
00887868130922	K122770	000
00887868130915	K122770	000
00887868106811	K122770	000
00887868106590	K122770	000
00887868106583	K122770	000
00887868106576	K122770	000
00887868106422	K122770	000