Pass 2 Spinal System

FDA 510(k) K062136 · Medicrea

Substantially Equivalent

510(k) numberK062136

Submission

Device name
Pass 2 Spinal System
Applicant
Medicrea
Round Rock, TX, US
Received
July 26, 2006
Decision date
October 6, 2006
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

Other 510(k)s with product code MNI

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K171497Mikron Spinal Fixation SystemMNI · Traditional Mikron Makina Sanayi Ticaret Co. , Ltd.10/12/2017SE
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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

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Questions and answers

When was Pass 2 Spinal System cleared by the FDA?

Pass 2 Spinal System (K062136) received a 510(k) decision of Substantially Equivalent on October 6, 2006, 72 days after the submission was received.

What is the product code of K062136?

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