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Centinel Spine, Inc.

USA · West Chester

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

8listed device types

Class I 6Class II 1Class III 1

plus 10 registration records and 14 510(k), 53 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 2Class III 2

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 12Class III 3IIa 1

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

1registrations

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 States10 registration records, 14 510(k), 53 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: CENTINEL SPINE, LLC · CENTINEL SPINE, INC.

FDA 510(k) clearances by year

12010

12012

12013

42014

32015

12018

12022

12024

12025

FDA listed device types

Rongeur 1Rasp 1Tray, Surgical 1Awl 1Tray, Surgical, Instrument 1Orthopedic Manual Surgical Instrument 1Manual Instruments Designed For Use With Total Disc Replacement Devices 1Prosthesis, Intervertebral Disc 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250554	prodisc® L Instruments	2025-04-25
US	K242869	prodisc® L Instruments	2024-12-17
US	K221848	prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments	2022-08-19
BR	80384860012	Prodisc C NOVA - Kit Instrumental Set	Class I
BR	80384860013	Prodisc C VIVO - Kit Instrumental Set	Class I

Centinel Spine, 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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