FDA 510(k) Applications Submitted by Genesys Spine

FDA 510(k) Number Submission Date Device Name Applicant
K192076 08/02/2019 Binary« Anterior Cervical Plate System Genesys Spine
K152099 07/28/2015 Genesys Spine Apache« Anchored Cervical Interbody Fusion System GENESYS SPINE
K180056 01/08/2018 Genesys Spine AIS-C Cervical Anchored Interbody System Genesys Spine
K181295 05/16/2018 Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine
K191489 06/04/2019 Genesys Spine 3DP Cervical Interbody System Genesys Spine
K161438 05/24/2016 Genesys Spine Apache« Anterior Lumbar Interbody Fusion System GENESYS SPINE
K111132 04/22/2011 GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM GENESYS SPINE
K103671 12/16/2010 GENESYS SPINE TILOCK SYSTEM GENESYS SPINE
K133911 12/23/2013 GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM GENESYS SPINE
K171656 06/05/2017 Genesys Spine Apache Interbody Fusion System Genesys Spine
K172469 08/15/2017 TiLock Modular Spinal System Genesys Spine
K173885 12/21/2017 Genesys Spine Binary Lumbar Plate System Genesys Spine
K220096 01/12/2022 Genesys Spine 3DP Lumbar Interbody System Genesys Spine
K192678 09/26/2019 Genesys Spine Binary« Lumbar Plate System Genesys Spine
K150812 03/26/2015 Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine
K161404 05/20/2016 Genesys Spine Apache« Lateral Lumbar Interbody Fusion System Genesys Spine
K153123 10/29/2015 Genesys Spine Apache Interbody Fusion System GENESYS SPINE
K100757 03/17/2010 TILOCK PEDICLE SCREW SYSTEM GENESYS SPINE
K103034 10/13/2010 GENESYS SPINE INTERBODY FUSION SYSTEM GENESYS SPINE
K130317 02/08/2013 GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM GENESYS SPINE
K130913 04/02/2013 GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM GENESYS SPINE
K152039 07/22/2015 Genesys Spine TiLock2 Spinal System Genesys Spine
K133245 10/22/2013 GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM GENESYS SPINE
K171838 06/20/2017 TiLock2 Spinal System Genesys Spine
K191748 07/01/2019 Genesys Spine Sacroiliac Joint Fusion System Genesys Spine
K161914 07/12/2016 Genesys Spine TiLock Cortical Spinal System Genesys Spine
K182987 10/29/2018 Genesys Spine 3DP Lumbar Interbody System Genesys Spine


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