510(k) Report

Devices descending from K102853

22 later devices reach Flamenco Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+1K123717UcentumUlrich GmbH & Co. KG2013171
+1K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K171321K2M Navigation InstrumentsK2m201711
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—