M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT

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 M2a-magnum Tri-spike Acetabular Component.

Pre-market Notification Details

• Device ID: K062995
• 510k Number: K062995
• Device Name: M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia S Beres
• Correspondent: Patricia S Beres; 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: 2006-10-02
• Decision Date: 2006-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304993693	K062995	000
00880304993594	K062995	000
00880304993600	K062995	000
00880304993617	K062995	000
00880304993624	K062995	000
00880304993631	K062995	000
00880304993648	K062995	000
00880304993655	K062995	000
00880304993662	K062995	000
00880304993679	K062995	000
00880304993686	K062995	000
00880304993587	K062995	000