510(k) Report

Devices descending from K021170

127 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—