Cleared Traditional

Response BandLoc Spinal Fixation

K200097 · OrthoPediatrics Corp. · Orthopedic

Mar 2020

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K200097 is an FDA 510(k) clearance for the Response BandLoc Spinal Fixation, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on March 16, 2020, 60 days after receiving the submission on January 16, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K200097 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2020
Decision Date	March 16, 2020
Days to Decision	60 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.