Cleared Traditional

K011406 - SPINAL MESH SYSTEM (FDA 510(k) Clearance)

K011406 · Medtronic Sofamor Danek, Inc. · Orthopedic device

Dec 2001

Decision

233d

Days

Class 2

Risk

K011406 is an FDA 510(k) clearance for the SPINAL MESH SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on December 27, 2001, 233 days after receiving the submission on May 8, 2001.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K011406 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 08, 2001
Decision Date	December 27, 2001
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF