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510(k) K180078

Device
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Applicant
Innovasis, Inc.
510(k) number
K180078
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-17
Date received
2018-01-10
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

Applicant Contact#

Contact
Marshall McCarty
Address
614 E 3900 S Salt Lake City UT US 84107 84107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.2026-05-29
K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.2026-05-28
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

Legacy Summary#

summary

FDA Review#

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