Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004369035

FEI Number

3004369035

Entity Name

I.T.S. GMBH

City/State/Country

LASSNITZHOEHE Steiermark, AT

Establishment Address

AUTAL 28, LASSNITZHOEHE Steiermark A-8301, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

I.T.S. GmbH (Owner Number: 9059922)

Owner / Operator Contact Address

Autal 28, Lassnitzhoehe, AT-6 8301, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130008

PMA Number

N/A

All Registered Proprietary Names

CAL - CALCANEUS locking PLATE FR.O.H. Calcaneus Repair System HLS - ITS Hand Locking Plates System CFN - Cannulated Femur Nail System CTN - Cannulated Tibia Nail System CHN - Cannulated Humeral Nail System PHL - PROXIMAL HUMERAL locking PLATE Small & Standard I.T.S. - LRS Locking Reconstruction System PTL - Proximal Medial/Lateral Tibia Locking Plate DFL - Distal Femur Locking Plate CALCANEUS DISTRACTOR PFL - PROlock FIBULA locking PLATE Quadrilaterale Plate Quatrolateral Column Plate Symphysis Plate Curved Posterior Wall Plate Extended J-Plate Posterior Wall Plates I & II Straight Plate Symphysis Plate Sacroiliac Joint Plates PRS/RX - Pelvis Reconstruction System R88 Curved Plate DHL - DISTAL HUMERAL locking PLATE System Dorsolateral Plate Medial Plate FLS - Foot Locking Plate System Twist-Off Screws System HOL - Hallux Osteotomy Locking Plate System HCS - Headless Compression Screw System DRILL BIT CLS - ANTERIOR CLAVICLE locking PLATE - MEDIAL CLS - ANTERIOR CLAVICLE locking PLATE - LATERAL CLS - CLAVICLE locking PLATE CLS - LATERAL CLAVICLE locking PLATE CLS - CLAVICLE locking PLATE 3.5mm PRL - PROlock Radius Locking Plate PROlock Distal Radius Plate DUL - Distal Ulna Locking Plate UOL - Ulna Osteotomy Locking Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDJ	Screw, Fixation, Bone, Non-Spinal, Metallic	Orthopedic	Class 2	888.3040	2007-11-20
NDF	Plate, Fixation, Bone, Non-Spinal, Metallic	Orthopedic	Class 2	888.3030	2007-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-11-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-11-04
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2014-11-04
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2014-03-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2014-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-03-17
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-03-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-09-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-09-07
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2004-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-09-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-09-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2005-06-02
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2007-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-08-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-08-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-08-19
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2004-08-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-02-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-02-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US, Inc. Email: usagent@Qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

I.T.S. GmbH

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number	Establishment Name	Location
1825034	BIOMET, INC.	WARSAW, IN, US
3013176080	ZIMMER PTE. LTD.	Singapore South East, SG
3035366890	Zimmer Biomet Pty Ltd	Sydney New South Wales, AU
3015542154	Zimmer Biomet Korea Ltd.	Seoul, KR
3011683674	Zimmer Biomet Taiwan Co., Ltd.	Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004369035. Last updated year: 2026. Please use registration number 3004369035 when referencing this establishment in official correspondence.