COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

BIOMET MANUFACTUTING CORP.

The following data is part of a premarket notification filed by Biomet Manufactuting Corp. with the FDA for Compress Segmental Humeral Replacement System.

Pre-market Notification Details

• Device ID: K123297
• 510k Number: K123297
• Device Name: COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
• Applicant: BIOMET MANUFACTUTING CORP. 56 EAST BELL DRIVE Warsaw, IN 46581
• Contact: Patricia Beres
• Correspondent: Patricia Beres; BIOMET MANUFACTUTING CORP. 56 EAST BELL DRIVE Warsaw, IN 46581
• Product Code: MBF
• CFR Regulation Number: 888.3670 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-10-22
• Decision Date: 2012-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304566859	K123297	000
00880304566842	K123297	000
00880304566835	K123297	000
00880304566828	K123297	000
00887868462818	K123297	000
00887868462801	K123297	000
00887868462795	K123297	000
00887868462788	K123297	000