Cleared Traditional

K201072 - Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (FDA 510(k) Clearance)

K201072 · Ensemble Orthopedics, LLC · Orthopedic device
Dec 2020
Decision
224d
Days
Class 2
Risk

K201072 is an FDA 510(k) clearance for the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161. This device is classified as a Prosthesis, Wrist, Carpal Trapezium (Class II - Special Controls, product code KYI).

Submitted by Ensemble Orthopedics, LLC (Austin, US). The FDA issued a Cleared decision on December 2, 2020, 224 days after receiving the submission on April 22, 2020.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.

Submission Details

510(k) Number K201072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2020
Decision Date December 02, 2020
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KYI - Prosthesis, Wrist, Carpal Trapezium
Device Class Class II - Special Controls
CFR Regulation 21 CFR 888.3770