Cleared Special

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K211313 · Synthes USA Products, LLC · Orthopedic

May 2021

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K211313 is an FDA 510(k) clearance for the MAXFRAME Multi-Axial Correction System (aka MAXFRAME), a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on May 25, 2021, 25 days after receiving the submission on April 30, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K211313 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2021
Decision Date	May 25, 2021
Days to Decision	25 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