510(k) Report

Devices descending from K010515

18 later devices reach Modification to Synergy Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+1K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+1K070966Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC20072—
+1K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.20023—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+2K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.20081—
+2K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…Sintea Biotech, Inc.20042—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC20120—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—