Cleared Traditional

LigaPASS

K172021 · Medicrea International SA · Orthopedic

Aug 2017

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K172021 is an FDA 510(k) clearance for the LigaPASS, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on August 30, 2017, 56 days after receiving the submission on July 5, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K172021 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2017
Decision Date	August 30, 2017
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.