Cleared Traditional

ACUMED MODULAR SHOULDER SYSTEM

K992525 · Acu Med, Inc. · Orthopedic
Feb 2000
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K992525 is an FDA 510(k) clearance for the ACUMED MODULAR SHOULDER SYSTEM, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 4, 2000, 191 days after receiving the submission on July 28, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K992525 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1999
Decision Date February 04, 2000
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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