Cleared Traditional

ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM

K042783 · The Anspach Effort, Inc. · Neurology
Dec 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K042783 is an FDA 510(k) clearance for the ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on December 17, 2004, 72 days after receiving the submission on October 6, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K042783 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2004
Decision Date December 17, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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