Cleared Traditional

CAPSTONE R SPINAL SYSTEM

K103731 · Medtronic Sofamor Danek · Orthopedic

Jul 2011

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K103731 is an FDA 510(k) clearance for the CAPSTONE R SPINAL SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on July 18, 2011, 208 days after receiving the submission on December 22, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K103731 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2010
Decision Date	July 18, 2011
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.