Cleared Traditional

AltiVate? Anatomic Pegged Glenoid with Markers

K203026 · Encore Medical, L.P. · Orthopedic

Dec 2020

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K203026 is an FDA 510(k) clearance for the AltiVate? Anatomic Pegged Glenoid 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 December 23, 2020, 82 days after receiving the submission on October 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K203026 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2020
Decision Date	December 23, 2020
Days to Decision	82 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