510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K191575ARx Spinal SystemLife Spine, Inc.201910—
+15K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+15K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+15K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+15K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+15K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+15K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+15K220025ARx® Spinal SystemLife Spine, Inc.20220—
+15K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+15K200070ARx Spinal SystemLife Spine, Inc.20209—
+16K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+16K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+16K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+16K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+16K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+16K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+16K210549ARx Spinal SystemLife Spine, Inc.20211—
+16K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+17K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—