510(k) Report

Devices descending from K964007

46 later devices reach Acromed Cable/Wire Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—