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ACUITY SURGICAL DEVICES, LLC

USA · Irving

✓ 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 0Class II 10Class III 0

plus 13 registration records and 8 510(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

0valid device licences

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 States13 registration records, 8 510(k), 0 PMA, 3 excluded

Manufacturer names merged into this page: ACUITY SURGICAL DEVICES, LLC

FDA 510(k) clearances by year

12021 · K201671

22022 · K222561

12023 · K230639

12024 · K241413

32025 · K251735

FDA listed device types

showing 8 of 10

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251735	Stabilis SA Cervical Stand-Alone System (Various PNs)	2025-07-30
US	K251335	Tera Lumbar Interbody Fusion System (Various PNs)	2025-06-02
US	K243386	Ventris Intervertebral Body Fusion Device	2025-04-22

ACUITY SURGICAL DEVICES, 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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