Cleared Traditional

K051105 - BASIS VERTEBRAL BODY SPACER (FDA 510(k) Clearance)

K051105 · Medtronic Sofamor Danek · Orthopedic device

Jun 2005

Decision

38d

Days

Class 2

Risk

K051105 is an FDA 510(k) clearance for the BASIS 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 June 9, 2005, 38 days after receiving the submission on May 2, 2005.

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

Submission Details

510(k) Number	K051105 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 02, 2005
Decision Date	June 09, 2005
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF