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510(k) DEN220015

Orthobond Mariner Pedicle Screw System by Orthobond Coporation — Product Code QZY

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 5, 2024
Date Received: February 28, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
Device Class: Class II
Regulation Number: 888.3071
Review Panel: OR
Submission Type

A spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is a rigid metallic implant system compromised of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The device includes a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body.