ELMDOWN SRL UNIPERSONALE

FDA Device Registration & Listing · milano Lombardy, IT · Registration 3008572623

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008572623
FEI Number
3008572623
Entity Name
ELMDOWN SRL UNIPERSONALE
City/State/Country
milano Lombardy, IT
Establishment Address
corso monforte 16, milano Lombardy 20123, IT
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
elmdown srl unipersonale (Owner Number: 10040927)
Owner / Operator Contact Address
corso monforte 16, milano, IT-MI 20122, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K033801
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2023-11-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-02-18
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2016-02-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-06-04
LOD Bone Cement Orthopedic Class 2 888.3027 2012-11-09
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-09
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-06-04

Official Correspondent

Michele Perrino

US Agent Details

Christine Brauer Business: Brauer Device Consultants, LLC Email: chris.brauer@comcast.net Phone: (301) 5451990

Related Public Records

Same Entity

elmdown srl unipersonale
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
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008572623. Last updated year: 2026. Please use registration number 3008572623 when referencing this establishment in official correspondence.
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