ULTRA-DRIVE 3

Instrument, Surgical, Sonic And Accessory/attachment

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ultra-drive 3.

Pre-market Notification Details

• Device ID: K031280
• 510k Number: K031280
• Device Name: ULTRA-DRIVE 3
• Classification: Instrument, Surgical, Sonic And Accessory/attachment
• Applicant: BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDX
• CFR Regulation Number: 888.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-22
• Decision Date: 2003-09-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00880304514034	K031280	000