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SeaSpine Orthopedics Corporation

FDA 510(k) & PMA Approved Devices — 67 products

Total Devices67
Categories12
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K193224 Daytona® Small Stature Growth Rod Conversion SetPGM2020-02-13 View
510(k) K192132 SeaSpine Beachside SystemMAX2019-12-03 View
510(k) K193040 Resorbable Mesh DeviceMQV2019-11-30 View
510(k) K191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemNKB2019-07-19 View
510(k) K183639 Mariner Outrigger Revision SystemNKB2019-05-23 View
510(k) K190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemOVE2019-04-29 View
510(k) K183083 Shoreline Cervical Interbody RT SystemODP2019-02-14 View
510(k) K181079 SeaSpine Regatta Lateral SystemMAX2018-07-18 View
510(k) K180686 SeaSpine Daytona Small Stature Spinal SystemNKB2018-05-14 View
510(k) K172517 SeaSpine Navigation SystemOLO2018-05-11 View
510(k) K173606 SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion DeviceOVD2018-04-13 View
510(k) K173334 SeaSpine Spinous Process SystemPEK2018-02-22 View
510(k) K180176 SeaSpine NewPort Spinal SystemNKB2018-02-20 View
510(k) K173882 SeaSpine Mariner Pedicle Screw SystemNKB2018-02-06 View
510(k) K173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemKWQ2018-01-24 View
510(k) K172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalODP2017-12-21 View
510(k) K173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD SystemMAX2017-12-04 View
510(k) K172130 Resorbable Mesh DeviceMQV2017-11-16 View
510(k) K173022 SeaSpine Ventura NanoMetalene SystemMAX2017-10-26 View
510(k) K171046 SeaSpine Cambria SystemODP2017-07-07 View

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