Cleared Traditional

K042783 - ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM (FDA 510(k) Clearance)

K042783 · The Anspach Effort, Inc. · Neurology device

Dec 2004

Decision

72d

Days

Class 2

Risk

K042783 is an FDA 510(k) clearance for the ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K042783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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