Cleared Traditional

AltiVate? Anatomic Shoulder AG e+? with Markers

K213387 · Encore Medical, L.P. · Orthopedic

Jul 2022

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K213387 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 July 7, 2022, 266 days after receiving the submission on October 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K213387 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2021
Decision Date	July 07, 2022
Days to Decision	266 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