Cleared Traditional

K200332 - EXPERT - Joint Fixation System (FDA 510(k) Clearance)

K200332 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device

Oct 2020

Decision

262d

Days

Class 2

Risk

K200332 is an FDA 510(k) clearance for the EXPERT - Joint Fixation System. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on October 29, 2020, 262 days after receiving the submission on February 10, 2020.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K200332 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 10, 2020
Decision Date	October 29, 2020
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF