510(k) Report

Devices descending from K061854

216 later devices reach Xia Titanium Spinal System and Xia Stainless Steel Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+12K254274ARx® SAI Implant SystemLife Spine, Inc.20260—