510(k) Report

Devices descending from K111136

304 later devices reach Expedium Spine System, Viper System, Viper 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—