510(k) Report

Devices descending from K061813

135 later devices reach Mantis Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—