E1 AVANTAGE HEAD

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for E1 Avantage Head.

Pre-market Notification Details

• Device ID: K101336
• 510k Number: K101336
• Device Name: E1 AVANTAGE HEAD
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Becky Earl
• Correspondent: Becky Earl; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: LPH
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-12
• Decision Date: 2011-01-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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