FDA.report

510(k) K123093

Device
STABILINK MIS SPINAL FIXATION SYSTEM
Applicant
SOUTHERN SPINE, LLC
510(k) number
K123093
Product code
KWP  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-20
Date received
2012-10-02
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
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
00815351022218StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2021-09-27
00815351022201StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2019-05-31
00815351022195StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2019-05-31
00815351022188StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2019-05-31
00815351022171StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2019-05-31
00815351022164StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2019-01-22
00815351022157StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2018-11-05
00815351022140StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2018-11-05
00815351022133StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2018-11-05
00815351022126StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2018-11-05
00815351022119StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2018-09-15
00815351022102StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2017-10-23
00815351022096StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2017-10-23
00815351021525StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021471StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021488StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021495StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021501StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021518StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021532StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021549StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021556StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021563StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021570StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021587StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021594StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021600StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021617StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021624StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22
00815351021631StabiLink®MIS Spinal Fixation SystemSouthern Spine LLC2016-04-22

Other 510(k) Records For Product Code KWP  

510(k)DeviceApplicantDecision date
K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2015-07-29
K150753OASYS SystemStryker Corporation2015-06-09
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.2015-06-04
K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC2015-04-29
K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28
K142253SOLSTICE OCT SystemLife Spine, Inc.2015-04-23
K150229SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K143249SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K142741OASYS SystemStryker Corporation2015-01-15
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014-12-22
K140734NEXTGEN ALTIUS OCT SYSTEMEbi, LLC2014-12-15
K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson2014-10-01
K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSynthes USA Products, LLC2014-09-25
K141284CASPIAN SPINAL SYSTEMK2m, Inc.2014-07-23
K133288CASPIAN OCT SPINAL SYSTEMK2m, Inc.2014-07-01

Legacy Summary

summary

FDA Review

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