FDA.report

510(k) K242771

Device
Tesera-k PL System and Tesera-k XL System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K242771
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-20
Date received
2024-09-13
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
N

Related Records

Applicant Contact

Contact
Dennis Ty
Address
1289 Bryn Mawr Ave., Suite A. Redlands CA US 92374 92374

FDA Registration Numbers

Source Documents

510(k) summary PDF

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