PolyLock Plating System

Plate, Fixation, Bone

Fusion Orthopedics

The following data is part of a premarket notification filed by Fusion Orthopedics with the FDA for Polylock Plating System.

Pre-market Notification Details

• Device ID: K211843
• 510k Number: K211843
• Device Name: PolyLock Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Fusion Orthopedics 4135 S Powder Road Mesa, AZ 85212
• Contact: Eli Jacobson
• Correspondent: Eli Jacobson; Fusion Orthopedics 4135 S Powder Road Mesa, AZ 85212
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-15
• Decision Date: 2022-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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