510(k) Report

Devices descending from K922543

640 later devices reach Z-Plate Anterior Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+9K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+9K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K240699SCARLET® AC-TiSpineart SA20240—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+10K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+10K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K180376K2M Patient Specific RodsK2m, Inc.20182—
+10K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+11K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+11K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+11K151727Everest Spinal SystemK2m, Inc.201511—
+12K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+12K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+12K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+12K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+12K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—