Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007303685

FEI Number

3007303685

Entity Name

OSTEOPORE INTERNATIONAL PTE LTD

City/State/Country

Singapore South West, SG

Establishment Address

2 Tukang Innovation Grove, #09-06 JTC MedTech Hub, Singapore South West 618305, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osteopore International Pte Ltd (Owner Number: 10027129)

Owner / Operator Contact Address

2 Tukang Innovation Grove, #09-06 JTC MedTech Hub, Singapore, SG-05 618305, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051093

PMA Number

N/A

All Registered Proprietary Names

Osteoplug Osteomesh Osteoplug-C Osteostrip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2008-10-06

Official Correspondent

Luke Ng

US Agent Details

Victoria Pankovich Business: EAS Consulting Group, LLC Email: usagent@easconsultinggroup.com Phone: (571) 4475500

Related Public Records

Same Entity

Osteopore International Pte Ltd

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 3007303685. Last updated year: 2026. Please use registration number 3007303685 when referencing this establishment in official correspondence.