510(k) Report

Devices descending from K943569

715 later devices reach Stryker Total Performance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—