TAPERLOC COMPLETE MICROPLASTY STEM

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Taperloc Complete Microplasty Stem.

Pre-market Notification Details

• Device ID: K110400
• 510k Number: K110400
• Device Name: TAPERLOC COMPLETE MICROPLASTY STEM
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Becky Earl
• Correspondent: Becky Earl; BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: JDL
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-11
• Decision Date: 2011-09-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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