Cleared Traditional

OLYMPIC Deformity Band System

K222097 · Astura Medical · Orthopedic

May 2023

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K222097 is an FDA 510(k) clearance for the OLYMPIC Deformity Band System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on May 4, 2023, 290 days after receiving the submission on July 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K222097 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2022
Decision Date	May 04, 2023
Days to Decision	290 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.