Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034532468

FEI Number

3034532468

Entity Name

ACTIS MEDICAL

City/State/Country

Torrensville South Australia, AU

Establishment Address

Unit 3/18 Ashwin Parade, Torrensville South Australia 5031, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACTIS MEDICAL (Owner Number: 10092149)

Owner / Operator Contact Address

18 Dequetteville Terrace, Kent Town, AU-SA 5067, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260090

PMA Number

N/A

All Registered Proprietary Names

Surgical Director A3 Access Drill Kit - Manual Orthopedic Instruments Smart Osteotomy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2025-05-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-12-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-18

Official Correspondent

No official correspondent registered.

US Agent Details

Joseph Azary Business: Aztech Regulatory and Quality LLC Email: aztechregulatory@gmail.com Phone: (203) 2426670

Related Public Records

Same Entity

ACTIS MEDICAL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
8040884	HILBRO (PVT) LTD.	SIALKOT Punjab, PK
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK
3004168759	CENTRAL SURGICAL CO. PVT. LTD.	Sialkot Punjab, PK
3004361445	AMERICAN MEDICAL ENDOSCOPY	Doral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034532468. Last updated year: 2026. Please use registration number 3034532468 when referencing this establishment in official correspondence.