Home›USA›SEASPINE ORTHOPEDICS CORPORATION

SEASPINE ORTHOPEDICS CORPORATION

USA · Carlsbad

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, Australia, Hong Kong, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

51listed device types

Class I 32Class II 18Class III 0unclassified 1

plus 147 registration records and 67 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIb 3

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States147 registration records, 67 510(k), 0 PMA, 4 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: SEASPINE ORTHOPEDICS CORPORATION

FDA 510(k) clearances by year

52016

72017

82018

62019

142020

92021

52022

52023

52024

22025

12026

FDA listed device types

showing 8 of 51

Posterior Cervical Screw System 1Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Spinous Process Plate 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Orthosis, Spinal Pedicle Fixation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253420	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 Sy	2026-07-01
US	K250908	Virata Spinal Fixation System	2025-06-18
US	K243659	FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments	2025-04-02
BR	80102511808	Instrumental Disc Prep	Class I
BR	80102511807	Instrumental Daytona	Class I
BR	80102511809	Instrumental PSP/PLIF	Class I

SEASPINE ORTHOPEDICS CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies