Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011386779

FEI Number

3011386779

Entity Name

INTEGRUM AB

City/State/Country

Molndal Vastra Gotaland, SE

Establishment Address

Gemenskapens gata 9, Molndal Vastra Gotaland SE-431 53, SE

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

Integrum AB (Owner Number: 10050627)

Owner / Operator Contact Address

Gemenskapens gata 9, Molndal, SE-O SE-431 53, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P190009

All Registered Proprietary Names

Osseoanchored prostheses for the rehabilitation of transfemoral amputees

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees	Unknown	Class 3	N/A	2022-01-24

Official Correspondent

Annika Fahlen

US Agent Details

Jeff Zanni Business: Integrum Inc. Email: jeff.zanni@integrum.se Phone: (800) 8058073

Related Public Records

Same Entity

Integrum AB

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011386779. Last updated year: 2026. Please use registration number 3011386779 when referencing this establishment in official correspondence.