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. |
K232097 |
07/13/2023 |
IdentiTi ALIF 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. |
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. |
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. |
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. |
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