Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011224555

FEI Number

3011224555

Entity Name

SYMATESE DEVICE

City/State/Country

IRIGNY Rhone, FR

Establishment Address

135 Route Neuve, IRIGNY Rhone 69540, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SYMATESE DEVICE (Owner Number: 10047448)

Owner / Operator Contact Address

135 Route Neuve, IRIGNY, FR-69 69540, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SYNTHES GmbH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2014-12-01

Official Correspondent

Gisela MAZIOL

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

SYMATESE DEVICE

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 3011224555. Last updated year: 2026. Please use registration number 3011224555 when referencing this establishment in official correspondence.