Cleared Traditional

K033926 - HOURGLASS VERTEBRAL BODY SPACER (FDA 510(k) Clearance)

K033926 · Medtronic Sofamor Danek · Orthopedic device

Jul 2004

Decision

202d

Days

Class 2

Risk

K033926 is an FDA 510(k) clearance for the HOURGLASS VERTEBRAL BODY SPACER. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on July 7, 2004, 202 days after receiving the submission on December 18, 2003.

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

Submission Details

510(k) Number	K033926 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 2003
Decision Date	July 07, 2004
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF