Cleared Traditional

K091883 - T2 SPINAL SYSTEM (FDA 510(k) Clearance)

K091883 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device

Sep 2009

Decision

89d

Days

Class 2

Risk

K091883 is an FDA 510(k) clearance for the T2 SPINAL SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on September 21, 2009, 89 days after receiving the submission on June 24, 2009.

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

Submission Details

510(k) Number	K091883 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 2009
Decision Date	September 21, 2009
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF