Cleared Traditional

The Gecko Spinal System

K200281 · Ortho Development Corporation · Orthopedic

Mar 2020

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K200281 is an FDA 510(k) clearance for the The Gecko Spinal System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on March 31, 2020, 56 days after receiving the submission on February 4, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K200281 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2020
Decision Date	March 31, 2020
Days to Decision	56 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.