510(k) Report

Devices descending from K213935

12 later devices reach PISCES-SA Standalone ALIF Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+1K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+1K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+2K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+2K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+2K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—