BIOMET CONCENTRIC HEX SCREW

Device, Fixation, Proximal Femoral, Implant

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Concentric Hex Screw.

Pre-market Notification Details

• Device ID: K781389
• 510k Number: K781389
• Device Name: BIOMET CONCENTRIC HEX SCREW
• Classification: Device, Fixation, Proximal Femoral, Implant
• Applicant: BIOMET, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JDO
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-08-10
• Decision Date: 1978-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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