510(k) Report

Devices descending from K013823

921 later devices reach Xia Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K182470Plateau Spacer SystemLife Spine20180—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K230329F3D Interbody SystemCorelink, LLC20230—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+12K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+13K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—