ECHO BI-METRIC PRESS-FIT STEMS

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 Echo Bi-metric Press-fit Stems.

Pre-market Notification Details

• Device ID: K070274
• 510k Number: K070274
• Device Name: ECHO BI-METRIC PRESS-FIT STEMS
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Susan Alexander
• Correspondent: Susan Alexander; BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-29
• Decision Date: 2007-04-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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