510(k) Report

Devices descending from K954696

24 later devices reach Rogozinski Thoracolumbar Spinal Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231658VEOS Spinal Fixation SystemSpineway20230—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K012273Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc20010—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—