Cleared Traditional

K200028 - Coronet Soft Tissue Fixation System
(FDA 510(k) Clearance)

K200028 · Conextions Medical · Orthopedic device

Mar 2020

Decision

58d

Days

Class 2

Risk

K200028 is an FDA 510(k) clearance for the Coronet Soft Tissue Fixation System. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Conextions Medical (Salt Lake City, US). The FDA issued a Cleared decision on March 4, 2020, 58 days after receiving the submission on January 6, 2020.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K200028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 06, 2020
Decision Date	March 04, 2020
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF