510(k) K242147
- Device
- Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K242147
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-20
- Date received
- 2024-07-23
- 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
Applicant Contact
- Contact
- Unnati Bhuptani
- Address
- 1950 Camino Vida Roble Carlsbad CA US 92008 92008
FDA Registration Numbers
- 3015709929
- 1450662
- 3021006165
- 3013820501
- 3010763958
- 2027062
- 3013393446
- 3015487912
- 3014252644
- 3004464325
- 2183744
- 3023852420
- 1834331
- 3009962553
- 1833824
- 3002807112
- 2032521
- 2031093
- 3009404219
- 3009504230
- 1219655
- 3036503733
- 3000170817
- 1319660
- 3017521423
- 3021945817
- 3012429289
- 3009756327
- 3010863450
- 3019767615
- 3012028003
- 3033739814
- 3006128100
- 3019837678
- 1030489
- 3004719693
- 3031081659
- 1649379
- 2183449
- 1723170
- 1060840
- 3004024955
- 3012120772
- 3005751028
- 3017048829
- 3009189869
- 3005083075
- 3009887475
- 9616680
- 3023138345
- 3010047454
- 3013546462
- 3014315669
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 3012447612
- 9611827
- 2531195
- 3006017180
- 3016237080
- 1835296
- 3007887127
- 3003898943
- 3008599979
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3020307303
- 3004893332
- 1833986
- 3009988302
- 1528646
- 1722511
- 3011181154
- 3036042032
- 3009132077
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00190376595924 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601243 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601236 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601229 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601212 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376596044 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376596037 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376596020 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376596013 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376596006 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595993 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595986 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595979 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595955 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595948 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601250 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595917 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595894 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595887 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595863 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595856 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595849 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595832 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595825 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595818 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595801 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595795 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595788 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376595771 | Calibrate | ALPHATEC SPINE, INC. | 2024-12-09 |
| 00190376601397 | AMP-LTX | ALPHATEC SPINE, INC. | 2024-12-09 |
Other 510(k) Records For Product Code MAX
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|---|
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. | 2026-05-09 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 |
| K251479 | Mobarn 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, LLC | 2025-09-18 |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 |