FDA.report

510(k) K180071

Device
STYLO Interbody Fusion Device
Applicant
Legend Spine Technologies
510(k) number
K180071
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2018-05-03
Date received
2018-01-09
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
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
Gwendolyn DeBoer
Address
1803 Apple Tree Ln. Bethlehem PA US 18015 18015

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
B638STT2209P05070STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05150STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05140STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05130STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05120STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05110STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05100STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05090STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05080STYLOLEGEND SPINE LLC2020-08-31
B638STT2409P05070STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05140STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05130STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05120STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05110STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05100STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05090STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05080STYLOLEGEND SPINE LLC2020-08-31
B638STT2209P05150STYLOLEGEND SPINE LLC2020-08-31
B638STT025110STYLOLEGEND SPINE LLC2019-03-26
B638STT025130STYLOLEGEND SPINE LLC2019-03-26
B638STT025120STYLOLEGEND SPINE LLC2019-03-26
B638STT030010STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005130STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005120STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005110STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005100STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005090STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005080STYLOLEGEND SPINE LLC2019-03-26
B638STT010241005070STYLOLEGEND SPINE LLC2019-03-26
B638STT140010STYLOLEGEND SPINE LLC2019-03-26

Other 510(k) Records For Product Code MAX  

510(k)DeviceApplicantDecision date
K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.2026-05-15
K260837VersaLift Expandable SystemLife Spine, Inc.2026-05-12
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc.2026-05-09
K261067BEE PLIF CageNGMedical GmbH2026-04-30
K254017SWINGO-3D Lumbar Cage SystemImplanet2026-02-26
K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04

Legacy Summary

summary

FDA Review

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