Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010986197

FEI Number

3010986197

Entity Name

MAC SURGICAL

City/State/Country

Brookvale New South Wales, AU

Establishment Address

6 Roger Street, Brookvale New South Wales 2100, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAC Surgical (Owner Number: 10086272)

Owner / Operator Contact Address

6 Roger Street, Brookvale, AU-NSW 2100, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2022-10-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-07-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-08-22
HWA	Impactor	Orthopedic	Class 1	888.4540	2022-10-26

Official Correspondent

Michael Stadler

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

MAC Surgical

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

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

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3017504598	RYDER PET SUPPLIES (CAMBODIA)CO., LTD	Sihanouk Preah Sihanouk, KH
1060680	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010986197. Last updated year: 2026. Please use registration number 3010986197 when referencing this establishment in official correspondence.