Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

SeaSpine Orthopedics Corporation

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

Total Devices67
Categories12
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K212692 Mariner Pedicle Screw SystemNKB2021-09-21 View
510(k) K212540 Explorer TO SystemMAX2021-09-10 View
510(k) K212139 Admiral ACP SystemKWQ2021-09-01 View
510(k) K211903 Shoreline Threaded TruProfile® PlateKWQ2021-08-30 View
510(k) K210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian SystemMAX2021-07-07 View
510(k) K211606 Mariner Deformity SystemNKB2021-06-23 View
510(k) K210583 SeaSpine WaveForm™ A Interbody SystemMAX2021-06-02 View
510(k) K201755 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemMAX2020-12-15 View
510(k) K201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside SystemMAX2020-11-25 View
510(k) K201073 Seaspine WaveForm C Interbody SystemOVE2020-09-18 View
510(k) K201646 Shoreline ACS (Anterior Cervical System)OVE2020-09-14 View
510(k) K202064 Admiral ACP SystemKWQ2020-08-26 View
510(k) K201240 Mariner Cap SystemOWI2020-08-05 View
510(k) K200879 SeaSpine Meridian System, SeaSpine Regatta Lateral SystemMAX2020-06-10 View
510(k) K200885 Meridian Anterior Plate System, Regatta Lateral Plate SystemKWQ2020-05-28 View
510(k) K200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)MQV2020-05-11 View
510(k) K193636 SeaSpine Reef TH SystemMAX2020-04-24 View
510(k) K193615 NorthStar™ OCT Spinal SystemNKG2020-03-25 View
510(k) K193418 SeaSpine Skipjack SystemMAX2020-03-13 View
510(k) K200381 Daytona® Small Stature Spinal SystemNKB2020-02-28 View

Page 2 of 4

↑