Cleared Traditional

K100448 - ASCENSION MODULAR TOTAL SHOULDER SYSTEM
(FDA 510(k) Clearance)

K100448 · Ascension Orthopedics, Inc. · Orthopedic

Aug 2010

Decision

194d

Days

Class 2

Risk

K100448 is an FDA 510(k) clearance for the ASCENSION MODULAR TOTAL SHOULDER SYSTEM, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 30, 2010, 194 days after receiving the submission on February 17, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K100448 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2010
Decision Date	August 30, 2010
Days to Decision	194 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