ORTHOCELL LIMITED

FDA Device Registration & Listing · Perth Western Australia, AU · Registration 3014015147

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
3014015147
FEI Number
3014015147
Entity Name
ORTHOCELL LIMITED
City/State/Country
Perth Western Australia, AU
Establishment Address
Building 191 Murdoch University, South Street, Murdoch, Perth Western Australia 6150, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Orthocell Limited (Owner Number: 10081188)
Owner / Operator Contact Address
Building 191 Murdoch University, South Street, Murdoch, Perth, AU-WA 6150, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243889
PMA Number
N/A

All Registered Proprietary Names

Striate+ perFORM Remplir

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2021-03-23
JXI Cuff, Nerve Neurology Class 2 882.5275 2025-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Orthocell Limited
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 3014015147. Last updated year: 2026. Please use registration number 3014015147 when referencing this establishment in official correspondence.
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