Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001917653

FEI Number

3001917653

Entity Name

OTTO BOCK ITALIA SRL

City/State/Country

BUDRIO Bologna, IT

Establishment Address

VIA FILIPPO TURATI 5/7, BUDRIO Bologna 40054, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ottobock SE & Co. KGaA (Owner Number: 8010097)

Owner / Operator Contact Address

Max-Naeder-Strasse 15, Duderstadt, DE-NI 37115, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smartspine SI Support Extension Orthosis Postural Extension Cyberspine TLSOx4 Ottobock TLSO Dosi EQ Smartspine Extension Brace Cybercross TLSO Dorso Osteo Care Spinal Orthosis Lumbo Direxa Stable Lumbo Sensa, women Spine Sport Dosi EQ X Multi 627, 631, 637 Lumbo Sensa Lumbo Direxa Woman Dorso Direxa Posture Dorso Carezza Posture Lumbo Carezza Lumbo Direxa High Dyneva Dorso Direxa Basic Dyneva light Hyperextension orthosis Hyperextension brace Lumbo Tristep Lumbo Direxa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2005-07-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2005-07-28

Official Correspondent

No official correspondent registered.

US Agent Details

Caleb Beck Business: Otto Bock HealthCare LP Email: Caleb.Beck@ottobock.com Phone: (801) 9746647

Related Public Records

Same Entity

Ottobock SE & Co. KGaA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007923118	Otto Bock Mobility Solutions GmbH	Koenigsee Thuringia, DE
9681725	Otto Bock Manufacturing Konigsee GmbH	Koenigsee Thuringia, DE
9611742	OTTO BOCK (CHINA) INDUSTRIES CO., LTD.	BEIJING, CN
3018070833	Ottobock Manufacturing Bulgaria EOOD	Blagoevgrad, BG
3005190268	Otto Bock Healthcare Products GmbH	Vienna Wien, AT

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3012453117	TREND MEDICAL, LLC	Bethlehem, PA, US
1226318	SPINAL TECHNOLOGY, LLC	West Yarmouth, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001917653. Last updated year: 2026. Please use registration number 3001917653 when referencing this establishment in official correspondence.