510(k) Report

Devices descending from K163364

25 later devices reach MOJAVE Expandable Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261049Scala® TLSpineart SA20260—
+1K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+1K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+1K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+1K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+1K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+1K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—