FDA.report

510(k) K232504

Device
Calibrate CCX Interbody System
Applicant
Alphatec Spine, Inc.
510(k) number
K232504
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-13
Date received
2023-08-18
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
Neha Mohindroo
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
00190376531496CalibrateALPHATEC SPINE, INC.2024-04-21
00190376533377CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533230CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533247CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533254CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533261CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533278CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533285CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533292CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533308CalibrateALPHATEC SPINE, INC.2024-04-20
00190376530277CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533322CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533339CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533346CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533353CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533360CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533520CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533384CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533391CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533407CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533414CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533421CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533438CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533445CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533452CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533469CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533476CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533483CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533490CalibrateALPHATEC SPINE, INC.2024-04-20
00190376533506CalibrateALPHATEC SPINE, INC.2024-04-20

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