Cleared Traditional

Mariner Cap System

K201240 · SeaSpine Orthopedics Corporation · Orthopedic

Aug 2020

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K201240 is an FDA 510(k) clearance for the Mariner Cap System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on August 5, 2020, 89 days after receiving the submission on May 8, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K201240 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2020
Decision Date	August 05, 2020
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.