510(k) Report

Devices descending from K063708

8 later devices reach 4S Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212700Dyflex-IITaeyeon Medical Co., Ltd.20220—
+1K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti.20135—
+1K092011Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar20090—
+2K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—