Cleared Traditional

Exactech? Equinoxe? Laser Cage Glenoid

K212356 · Exactech, Inc. · Orthopedic

Mar 2022

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K212356 is an FDA 510(k) clearance for the Exactech? Equinoxe? Laser Cage Glenoid, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 4, 2022, 218 days after receiving the submission on July 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K212356 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2021
Decision Date	March 04, 2022
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660