FDA.report

510(k) K992147

Device
Triple-fix Spinal Fixation System
Applicant
ADVANCED SPINE TECHNOLOGY, INC.
510(k) number
K992147
Product code
MNI
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-28
Date received
1999-06-24
Regulation
888.3070
Classification name
Orthosis, Spinal Pedicle Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GORDON TAO
Address
3645 Grand Ave., Suite 304 Oakland CA US 94610 94610

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MNI

510(k)DeviceApplicantDecision date
K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.2017-10-12
K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.2016-10-04
K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.2016-08-22
K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.2016-06-29
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.2016-04-04
K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.2016-04-01
K160003Sniper (R) Spine SystemSpine Wave, Inc.2016-02-26
K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co. , Ltd.2016-02-01
K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.2015-12-11
K150684WASTON General Spinal SystemChangzhou Waston Medical Appliance Co., Ltd.2015-11-18
K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.2015-09-25
K151592Gemmed pedicle screw spinal systemSuzhou Gemmed Medical Instrument Co., Ltd.2015-09-24
K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC2015-09-17
K152098ODALYS Pedicle Screw SystemKisco International2015-09-17
K152174Sniper Spine SystemSpine Wave, Inc.2015-08-31