Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043534478

FEI Number

3043534478

Entity Name

AMBER IMPLANTS BV

City/State/Country

The Hague Zuid-Holland, NL

Establishment Address

Prinses Beatrixlaan 546, 2595 BM, The Hague, The Hague Zuid-Holland 2595BM, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Amber Implants (Owner Number: 10094065)

Owner / Operator Contact Address

1660 International Drive, Suite 600, McLean, VA 22102, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250637

PMA Number

N/A

All Registered Proprietary Names

VCFix® spinal system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2026-01-26

Official Correspondent

Amanda da Silva

US Agent Details

Sarah Pleaugh Email: spleaugh@mcra.com Phone: (202) 7423859

Related Public Records

Same Entity

Amber Implants

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 3043534478. Last updated year: 2026. Please use registration number 3043534478 when referencing this establishment in official correspondence.