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Spinecraft, Inc.

USA · Westmont

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

12listed device types

Class I 1Class II 11Class III 0

plus 18 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States18 registration records, 18 510(k), 0 PMA

Manufacturer names merged into this page: SPINECRAFT LLC

FDA 510(k) clearances by year

22006

12009

22010

22011

22013

22015

12018

22021

12022

12023

22026

FDA listed device types

showing 8 of 12

Posterior Cervical Screw System 1Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253260	ORIO-3D Cage System	2026-04-16
US	K260015	ANTERIS Thoracolumbar Plate System	2026-03-04
US	K223301	ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System	2023-07-20

Spinecraft, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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