Optima, Spinal System

FDA 510(k) K024096 · U&I Corp., America

Substantially Equivalent

510(k) numberK024096

Submission

Device name
Optima, Spinal System
Applicant
U&I Corp., America
Murray, UT, US
Received
December 12, 2002
Decision date
March 12, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNI – Orthosis, Spinal Pedicle Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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K160731LumFix Spinal Fixation SytemMNI · Traditional CG Bio Co., Ltd.10/04/2016SE
K151458Double Medical Universal Spine SystemMNI · Traditional Double Medical Technology, Inc.08/22/2016SE
K153273MySpine Pedicle Screw Placement Guides - LPMNI · Traditional Medacta International S.A.06/29/2016SE
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special Spinevision S.A.04/04/2016SE
K160320PremierMNI · Traditional Shandong Weigao Orthopaedic Device Co., Ltd.04/01/2016SE
K160003Sniper (R) Spine SystemMNI · Traditional Spine Wave, Inc.02/26/2016SE
K152324YAHUA Spinal SystemMNI · Traditional Beijing Weigao Yahua Artificial Joint…02/01/2016SE
K143222FIREFLY Pedicle Screw Navigation GuideMNI · Traditional Mighty Oak Medical, Inc.12/11/2015SE
K150684WASTON General Spinal SystemMNI · Traditional Changzhou Waston Medical Appliance Co., Ltd.11/18/2015SE

More from Changzhou Waston Medical Appliance Co., Ltd.

510(k)DeviceDecision
K031585U&I, Optima, Spinal SystemMNH · Special 06/27/2003SE
K031595U & I America Spinal Hook SystemKWP · Traditional 06/24/2003SE

Questions and answers

When was Optima, Spinal System cleared by the FDA?

Optima, Spinal System (K024096) received a 510(k) decision of Substantially Equivalent on March 12, 2003, 90 days after the submission was received.

What is the product code of K024096?

The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.