Cleared Special

AltiVate Reverse Humeral Stem, 48mm

K190290 · Encore Medical, L.P. · Orthopedic

Apr 2019

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K190290 is an FDA 510(k) clearance for the AltiVate Reverse Humeral Stem, 48mm, 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 April 26, 2019, 74 days after receiving the submission on February 11, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K190290 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	April 26, 2019
Days to Decision	74 days
Submission Type	Special
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