Cleared Abbreviated

AltiVate? Anatomic Shoulder AG e+? with Markers

K222592 · Encore Medical, L.P. · Orthopedic

Jun 2023

Decision

301d

Days

Class 2

Risk

About This 510(k) Submission

K222592 is an FDA 510(k) clearance for the AltiVate? Anatomic Shoulder AG e+? with Markers, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 23, 2023, 301 days after receiving the submission on August 26, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K222592 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2022
Decision Date	June 23, 2023
Days to Decision	301 days
Submission Type	Abbreviated
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