510(k) Report

Devices descending from K143578

210 later devices reach SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K223326Axiom PSR SystemRestor3D202301
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—