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Spinal Kinetics, LLC

USA · Sunnyvale

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Russia — 5 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k), 17 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States0 registration records, 2 510(k), 17 PMA, 13 excluded

Brazil4 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SPINAL KINETICS LLC · SPINAL KINETICS, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241117	M6-C Single Use, Disposable Instrumentation	2024-06-21
US	K220861	M6-C Artificial Cervical Disc Instruments AS	2022-06-02
BR	10392060163	Kit Instrumental Spinal Kinetics ANC	Class I
BR	10392060164	Kit Instrumental Spinal Kinetics NANC	Class I
BR	10355870071	INSTRUMENTOS SPINAL KINETICS NANC	Class I

Spinal Kinetics, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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