510(k) Report

Devices descending from K023644

122 later devices reach Modification to Incompass Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—