FDA.report

510(k) K231438

Device
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
Applicant
Alphatec Spine, Inc.
510(k) number
K231438
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-13
Date received
2023-05-17
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Unnati Bhuptani
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376529479CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529615CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529608CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529592CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529585CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529578CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529561CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529554CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529547CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529530CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529523CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529516CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529509CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529493CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529486CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529622CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529462CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529455CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529448CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529431CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529424CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529417CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529400CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529394CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529387CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529370CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529363CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529356CalibrateALPHATEC SPINE, INC.2023-12-03
00190376529349CalibrateALPHATEC SPINE, INC.2023-12-03
00190376521626CalibrateALPHATEC SPINE, INC.2023-12-03

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