Cleared Traditional

K063491 - T2 SCEPTOR SPINAL SYSTEM (FDA 510(k) Clearance)

K063491 · Medtronic Sofamor Danek · Orthopedic device

Mar 2007

Decision

108d

Days

Class 2

Risk

K063491 is an FDA 510(k) clearance for the T2 SCEPTOR 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 (Memphis, US). The FDA issued a Cleared decision on March 5, 2007, 108 days after receiving the submission on November 17, 2006.

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

Submission Details

510(k) Number	K063491 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 2006
Decision Date	March 05, 2007
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF