BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

Plate, Fixation, Bone

BIOMET MICROFIXATION, INC.

The following data is part of a premarket notification filed by Biomet Microfixation, Inc. with the FDA for Biomet Microfixation Sternalock Blu Sternal Closure System.

Pre-market Notification Details

• Device ID: K110574
• 510k Number: K110574
• Device Name: BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Contact: Sheryl Malmberg
• Correspondent: Sheryl Malmberg; BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-01
• Decision Date: 2011-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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