510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220015Unknown

Orthobond Mariner Pedicle Screw System

Orthobond Coporation, Monmouth NJ / Direct, Unknown
FDA source (opens on fda.gov)

DEN220015 is the FDA 510(k) clearance record for Orthobond Mariner Pedicle Screw System, a class II device, cleared for Orthobond Coporation on under FDA product code QZY (Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating). FDA's definition for product code QZY reads: "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...". FDA records list one 510(k) clearance for Orthobond Coporation. As of , FDA records show no recalls naming DEN220015.

Clearance record

Decision date
Received
(767 days to decision)
Product code
QZY Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
Regulation
21 CFR 888.3071
Device class
Class II
Review panel
Orthopedic
Applicant
Orthobond Coporation 1 Deerpark Dr., Monmouth NJ
Third party review
No

Clearances, product code QZY

Trailing 12 months

FDA records hold no clearances under product code QZY in the trailing twelve months.

FDA records show no clearances under product code QZY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260