FDA 510(k) Applications Submitted by ALPHATEC SPINE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K230721 03/15/2023 ATEC Lateral Plate System Alphatec Spine, Inc.
K221926 07/01/2022 Invictus« Bone Cement, Invictus Spinal Fixation System Alphatec Spine, Inc.
K220782 03/17/2022 IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System, IdentiTiÖ C Alphatec Spine, Inc.
K241519 05/29/2024 Invictus« Small Stature Spinal Fixation System Alphatec Spine, Inc.
K232097 07/13/2023 IdentiTi ALIF Interbody Systems Alphatec Spine, Inc.
K243461 11/08/2024 Calibrate Interbody Systems Alphatec Spine, Inc.
K100138 01/19/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K100685 03/10/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K090779 03/23/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K111634 06/13/2011 XENON(TM) PEDICLE SCREW SYSTEM ALPHATEC SPINE, INC.
K093077 09/30/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K191311 05/15/2019 ATEC Lateral Interbody System Alphatec Spine, Inc.
K181453 06/01/2018 ATEC ALIF Spacer System Alphatec Spine, Inc.
K181435 06/01/2018 ATEC Cervical Spacer System Alphatec Spine, Inc.
K181677 06/26/2018 Kodiak Spinal Fixation System Alphatec Spine, Inc.
K182746 09/28/2018 ATEC ALIF and LLIF Spacer System Alphatec Spine, Inc.
K192938 10/18/2019 InvictusÖ Spinal Fixation System Alphatec Spine, Inc.
K183705 12/31/2018 IdentiTi Porous Ti Interbody System Alphatec Spine, Inc.
K211873 06/17/2021 PSX Interbody System Alphatec Spine, Inc.
K232275 07/31/2023 Invictus« Spinal Fixation System Alphatec Spine, Inc.
K222455 08/15/2022 Calibrate LTX Interbody System Alphatec Spine, Inc.
K203056 10/08/2020 InvictusÖ Spinal Fixation System Alphatec Spine, Inc.
K211987 06/28/2021 ATEC Alignment App Alphatec Spine, Inc.
K213849 12/10/2021 SafeOp 2: Neural Informatix System Alphatec Spine, Inc.
K052201 08/12/2005 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC.
K181980 07/25/2018 OsseoScrew System Alphatec Spine, Inc.
K090228 01/30/2009 ROC LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC.
K111076 04/18/2011 SOLANAS AVALON POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC.
K101255 05/04/2010 ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC.
K102820 09/28/2010 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY ALPHATEC SPINE, INC.
K081730 06/18/2008 NOVEL CERVICAL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K090425 02/19/2009 GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM ALPHATEC SPINE, INC.
K080699 03/12/2008 NOVEL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K090782 03/23/2009 NOVEL ALIF SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K081158 04/23/2008 ZODIC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K071890 07/09/2007 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K072081 07/30/2007 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM ALPHATEC SPINE, INC.
K102402 08/24/2010 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K130548 03/04/2013 EPICAGE INTERBODY FUSION DEVICE ALPHATEC SPINE, INC.
K123623 11/23/2012 ILLICO MIS POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC.
K143740 12/30/2014 Battalion Universal Spacer System ALPHATEC SPINE, INC.
K232504 08/18/2023 Calibrate CCX Interbody System Alphatec Spine, Inc.
K223611 12/02/2022 Calibrate LTX Interbody System Alphatec Spine, Inc.
K110170 01/20/2011 RAPTOR FACET FIXATION SYSTEM ALPHATEC SPINE, INC.
K103205 11/01/2010 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC.
K070681 03/12/2007 NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM ALPHATEC SPINE, INC.
K091189 04/23/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K061321 05/11/2006 ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX ALPHATEC SPINE, INC.
K071380 05/17/2007 MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC.
K063668 12/11/2006 ROC LUMBAR SYSTEM ALPHATEC SPINE, INC.
K143149 11/03/2014 Arsenal Spinal Fixation System ALPHATEC SPINE, INC.
K153603 12/17/2015 Alphatec Navigation Instruments ALPHATEC SPINE, INC.
K133221 10/18/2013 ARSENAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K200936 04/08/2020 InvictusÖ CT Spinal Fixation System Alphatec Spine, Inc.
K191723 06/27/2019 ATEC IOM Accessory Instruments Alphatec Spine, Inc.
K202812 09/24/2020 IdentiTi Cervical Standalone Interbody System Alphatec Spine, Inc.
K182808 10/03/2018 Aspida« Anterior Lumbar Plating System Alphatec Spine, Inc.
K203125 10/19/2020 InvictusÖ OCT Spinal Fixation System Alphatec Spine, Inc.
K200995 04/16/2020 InsigniaÖ Anterior Cervical Plate System Alphatec Spine, Inc.
K211805 06/11/2021 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System Alphatec Spine, Inc.
K221821 06/23/2022 ATEC IOM Accessory Instruments Alphatec Spine, Inc.
K232173 07/21/2023 Ascend VBR System, Ascend NanoTec VBR System Alphatec Spine, Inc.
K232345 08/04/2023 ATEC Posterior Navigated Disc Prep Instruments Alphatec Spine, Inc.
K242364 08/09/2024 IdentiTiÖ II Interbody System Alphatec Spine, Inc.
K202327 08/17/2020 InvictusÖ OsseoScrew« System Alphatec Spine, Inc.
K202587 09/08/2020 ATEC Lateral Interbody System Alphatec Spine, Inc.
K213443 10/25/2021 InsigniaÖ Anterior Cervical Plate System Alphatec Spine, Inc.
K213460 10/27/2021 Invictus Spinal Fixation System Alphatec Spine, Inc.
K223765 12/15/2022 ATEC Lateral Navigation Instruments Alphatec Spine, Inc.
K214006 12/22/2021 Invictus« Spinal Fixation System Alphatec Spine, Inc.
K232413 08/10/2023 Fusion Robotic Navigation System Alphatec Spine, Inc.
K131119 04/22/2013 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC.
K123218 10/15/2012 ILLICO FS FACET FIXATION SYSTEM ALPHATEC SPINE, INC.
K123993 12/26/2012 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM ALPHATEC SPINE, INC.
K240199 01/25/2024 IntraOp Alignment System Alphatec Spine, Inc.
K251080 04/08/2025 IdentiTi II Cervical Interbody System Alphatec Spine, Inc.
K231438 05/17/2023 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System Alphatec Spine, Inc.
K232044 07/10/2023 Invictus Robotic Navigation Instruments Alphatec Spine, Inc.
K242147 07/23/2024 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System Alphatec Spine, Inc.
K234092 12/26/2023 SafeOp 3: Neural Informatix Systeem Alphatec Spine, Inc.


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