510(k) Report

Devices descending from K120570

322 later devices reach Choice Spine Vertebral Body Replacement (VBR) Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—