Cleared Special

SALVATION External Fixation System

K180832 · Wrightmedicaltechnologyinc · Orthopedic

Jun 2018

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K180832 is an FDA 510(k) clearance for the SALVATION External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on June 6, 2018, 68 days after receiving the submission on March 30, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K180832 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2018
Decision Date	June 06, 2018
Days to Decision	68 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030