FDA 510(k) Applications Submitted by Franck Pennesi

FDA 510(k) Number Submission Date Device Name Applicant
K190071 01/15/2019 Perla« Posterior Cervico-Thoracic Fixation System SPINEART
K130267 02/04/2013 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K190322 02/13/2019 SCARLET« AC-T Secured Anterior Cervical Cage Spineart
K210472 02/17/2021 SPINEART Navigation Instrument System Spineart
K230583 03/02/2023 Tryptik Ti Spineart SA
K200571 03/04/2020 PERLA« Posterior Occipito-Cervico-Thoracic Fixation System SPINEART
K230774 03/21/2023 PERLA« TL System; TEKTONA« HV US Bone Cement Spineart
K190877 04/04/2019 Juliet« Ti LL Lumbar Interbody Device SPINEART
K140948 04/14/2014 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K111127 04/21/2011 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K081165 04/24/2008 ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K151104 04/24/2015 OTELO LL SPINEART
K141135 05/01/2014 JULIET LL SPINEART
K141314 05/20/2014 SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION SPINEART
K141508 06/06/2014 ROMEO 2 PAD POSTERIOR AXIAL DEVICE SPINEART
K101678 06/15/2010 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K171797 06/16/2017 TRYPTIK2 C-Plate Anterior Cervical Plate System Spineart
K101720 06/18/2010 JULIET OL SPINEART
K091873 06/23/2009 TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S SPINEART
K151695 06/23/2015 Romeo posterior osteosynthesis system SPINEART
K081888 07/02/2008 DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE SPINEART
K141835 07/07/2014 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS SPINE ART
K172065 07/07/2017 SCARLET AC-T SPINEART
K181818 07/09/2018 Scarlet AL-T Spineart
K161888 07/11/2016 JULIET« LL Lateral Lumbar Cage SPINEART
K172101 07/12/2017 ROMEO« 2 Posterior Osteosynthesis System Spineart
K142277 08/15/2014 JULIET PO SPINEART
K093170 10/07/2009 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K153042 10/19/2015 TRYPTIK2C-plate Anterior Cervical Plate System SPINEART
K192993 10/25/2019 SCARLET AL-T Spineart
K213470 10/28/2021 PERLA« TL Posterior Osteosynthesis System Spineart
K203222 11/02/2020 PERLA TL Posterior Osteosynthesis System SPINEART
K143214 11/10/2014 SCARLET« AC-T Secured Anterior Cervical Cage SPINEART
K133557 11/19/2013 JULIET LL LATERAL LUMBAR CAGE SPINEART
K153386 11/23/2015 Perla Posterior Cervico-Thoracic Fixation system SPINEART
K203506 11/30/2020 PERLA« TL posterior osteosynthesis system SPINEART
K173702 12/04/2017 Juliet Ti LL SPINEART
K193396 12/06/2019 PERLA« TL posterior osteosynthesis system Spineart
K153621 12/18/2015 Juliet« Ti SPINEART
K093936 12/22/2009 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART
K183630 12/26/2018 SPINEART Navigation Instrument System Spineart SA


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