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Republic Spine, LLC

USA · Fort Lauderdale

✓ 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

7listed device types

Class I 0Class II 7Class III 0

plus 6 registration records and 7 510(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 States6 registration records, 7 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: REPUBLIC SPINE

FDA 510(k) clearances by year

12015 · K150283

12018 · K181495

22019 · K190398

22021 · K212028

12023 · K223096

FDA listed device types

Thoracolumbosacral Pedicle Screw System 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Orthopedic Stereotaxic Instrument 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223096	Dark Star Deformity Pedicle Screw System	2023-05-26
US	K212028	Dark Star Navigation Instrument System	2021-09-27
US	K201420	Republic Spine Dark Star Spinal System	2021-03-05

Republic 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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