Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010502940

FEI Number

3010502940

Entity Name

INTRAUMA

City/State/Country

Bruino Torino, IT

Establishment Address

Via Antonio Meucci 5, Bruino Torino 10090, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTRAUMA (Owner Number: 10085520)

Owner / Operator Contact Address

Via Antonio Meucci, 5, Bruino, IT-TO 10090, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INTRAUMA SURGICAL INSTRUMENT Elos Intramedullary Nailing System Kite Distal Fibula Kit INTRAUMA SURGICAL INSTRUMENT INTRAUMA SURGICAL INSTRUMENT INTRAUMA SURGICAL INSTRUMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-11-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-07-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-09-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-09-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-27
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2025-11-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-11-24
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-11-24

Official Correspondent

Stefano Pullega

US Agent Details

Gabriel Emilio Santha Email: gabriel.santha@intrauma.com Phone: (954) 9998203

Related Public Records

Same Entity

INTRAUMA

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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010502940. Last updated year: 2026. Please use registration number 3010502940 when referencing this establishment in official correspondence.