Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004450973

FEI Number

3004450973

Entity Name

APATECH LTD.

City/State/Country

ELSTREE Hertfordshire, GB

Establishment Address

360 CENTENNIAL AVENUE, CENTENNIAL PARK, ELSTREE Hertfordshire WD6 3TJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040082

PMA Number

N/A

All Registered Proprietary Names

Ostene Ostene Actifuse Ostene Ostene Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS Ostene Ostene Actifuse ALTAPORE Altapore Shape Actifuse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-20
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2015-01-22
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2015-01-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-04-16
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-05-14
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09

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3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
3005972619	ABYRX, INC.	Stamford, CT, US
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
1000512200	FILLTECH USA, LLC	Rockwell, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004450973. Last updated year: 2026. Please use registration number 3004450973 when referencing this establishment in official correspondence.