FDA.report

510(k) K063764

Device
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM
Applicant
SOUTHERN SPINE, LLC
510(k) number
K063764
Product code
KWQ  
Decision
Substantially Equivalent (SESE)
Decision date
2007-05-16
Date received
2006-12-20
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
JULIE STEPHENS
Address
111 Laurel Ridge Dr. Alpharetta GA US 31201 31201

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00815351021990Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2016-08-04
00815351022041Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2016-08-04
00815351020290Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020245Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020252Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020269Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020276Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020283Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020306Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020313Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020320Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020337Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020344Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020351Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020368Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020375Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020382Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-19
00815351020238Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-16
00815351020221Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-16
00815351020214Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-16
00815351020207Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-16
00815351020191Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical SystemSouthern Spine LLC2015-10-16

Other 510(k) Records For Product Code KWQ  

510(k)DeviceApplicantDecision date
K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-14
K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2026-05-06
K260570corra™ cervical plating systemCarlsmed, Inc.2026-04-22
K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC2026-03-27
K260015ANTERIS Thoracolumbar Plate SystemSpineCraft2026-03-04
K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.2026-03-03
K254182AsterOsteonic Co., Ltd.2026-02-26
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
K252611aprevo® cervical plating systemCarlsmed, Inc.2025-12-22
K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28
K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.2025-07-11
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14

Legacy Summary

summary

FDA Review

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