SeaSpine Orthopedics Corporation FDA Approvals

0 new drug approvals and 27 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy510(k)Jul 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
Virata Spinal Fixation System510(k)Jun 18, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 18, 2025
FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments510(k)Apr 2, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 2, 2025
Cove Putty, OsteoCove Putty510(k)Sep 25, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 25, 2024
Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System510(k)Jun 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 20, 2024
Reef L Interbody System; WaveForm L Interbody System510(k)Apr 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 26, 2024
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System510(k)Apr 19, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 19, 2024
Meridian Interbody System; WaveForm A Interbody System510(k)Jan 12, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 12, 2024
Shoreline ACS Interbody System; Shoreline RT Interbody System510(k)Nov 28, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
Cove Strip, OsteoCove Strip510(k)Sep 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 27, 2023
Cove Putty, OsteoCove Putty510(k)Sep 14, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 14, 2023
Cove Strip510(k)Aug 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 21, 2023
Manta Ray TDF Spacer510(k)Feb 3, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 3, 2023
SeaSpine 7D Navigation Instruments510(k)Dec 9, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 9, 2022
WaveForm A Interbody System510(k)Nov 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 7, 2022
Mariner RDX System510(k)Sep 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 7, 2022
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System510(k)May 10, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 10, 2022
WaveForm L System, WaveForm TO System, WaveForm TA System510(k)May 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 4, 2022
SeaSpine WaveForm C Interbody System510(k)Dec 14, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 14, 2021
SeaSpine WaveForm, C Interbody System510(k)Dec 9, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 9, 2021
Mariner Pedicle Screw System510(k)Sep 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 21, 2021
Explorer TO System510(k)Sep 10, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 10, 2021
Admiral ACP System510(k)Sep 1, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 1, 2021
Shoreline Threaded TruProfile® Plate510(k)Aug 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 30, 2021
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD 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 System510(k)Jul 7, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 7, 2021
Mariner Deformity System510(k)Jun 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 23, 2021
SeaSpine WaveForm A Interbody System510(k)Jun 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2021

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