Cleared Traditional

AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

K172351 · Encore Medical, L.P. · Orthopedic

Oct 2017

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K172351 is an FDA 510(k) clearance for the AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert, 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 October 30, 2017, 88 days after receiving the submission on August 3, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K172351 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2017
Decision Date	October 30, 2017
Days to Decision	88 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