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SURGICAL DESIGN, INC.

USA · Lorton

✓ 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

9listed device types

Class I 4Class II 5Class III 0

plus 8 registration records and 6 510(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 States8 registration records, 6 510(k), 0 PMA, 152 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 11 excluded

Manufacturer names merged into this page: ZINNANTI SURGICAL DESIGN GROUP INC · SURGICAL DESIGN, INC.

FDA 510(k) clearances by year

11994 · K934817

11996 · K961243

11999 · K991852

12005 · K043533

12006 · K060412

12020 · K201079

FDA listed device types

showing 8 of 9

Electrosurgical, Cutting & Coagulation & Accessories 1Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) 1Curette, Suction, Endometrial (And Accessories) 1Tubing, Noninvasive 1Laparoscope, General & Plastic Surgery 1Forceps, Biopsy, Non-Electric 1Microtome, Accessories 1Blade, Scalpel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201079	Aurora® Anterior Lumbar Plate Sytstem	2020-08-05
US	K060412	ACTIVE UNICOMPARTMENTAL KNEE SYSTEM	2006-05-17
US	K043533	SURGICAL DESIGN CIRCUMCISION CLAMP	2005-04-01

SURGICAL DESIGN, 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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