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NANOVIS SPINE, LLC

USA · Columbia City

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

10listed device types

Class I 6Class II 4Class III 0

plus 16 registration records and 3 510(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

pendingnot queried

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 States16 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: NANOVIS SPINE, LLC

FDA 510(k) clearances by year

12015 · K143706

12016 · K162250

12020 · K193211

FDA listed device types

showing 8 of 10

Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Thoracolumbosacral Pedicle Screw System 1Screwdriver 1Extractor 1Tamp 1Bender 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193211	Nano FortiFix® System	2020-03-20
US	K162250	FortiBridge Anterior Cervical Plate System	2016-10-26
US	K143706	FortiBridge Anterior Cervical Plate System	2015-04-10

NANOVIS SPINE, LLC

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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