510(k) Report

Devices descending from K150619

107 later devices reach CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K223326Axiom PSR SystemRestor3D202301
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—