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Apatech Ltd

US Last updated 30 May 2026

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Devices
44
Registries
GUDIDEUDAMEDFDA 510(k)FDA
FDA recalls
1

Catalogue44

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2015

    • 18 Aug 2015 Z-1922-2016 Class II Terminated Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.via FDA establishment APATECH LTD.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Apatech Ltd. ELSTREE Hertfordshire · GB FEI 3004450973

What Apatech Ltd makes

Apatech Ltd manufactures synthetic bone matrix implants and bone wax designed for surgical applications. Their portfolio includes granular, flowable, and pre-shaped bone graft substitutes, as well as antimicrobial bone wax variants for use in orthopedic and spinal procedures. These products are intended to support bone healing and filling defects without antimicrobial properties in most formulations.

The company’s devices are classified under FDA categories II and U, with regulatory submissions including 510(k) clearances and UDI listings. Their products are authorised for use in the United States, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Apatech Ltd manufacture?

Apatech Ltd specializes in synthetic bone matrix implants and bone wax. Their portfolio includes granular, flowable, and pre-shaped bone graft substitutes like Actifuse Granules, Actifuse Flow, and Actifuse Shape, as well as bone wax variants such as Actifuse ABX (antimicrobial) and ALTAPORE. These devices are designed for surgical applications in orthopedic and spinal procedures to support bone healing and defect filling.

Where is Apatech Ltd based, and where are their devices authorised for use?

Apatech Ltd is based in the United States. Their devices are authorised for use in the US, where they undergo regulatory review through pathways like FDA 510(k) clearances and UDI listings. The company’s focus is on the US market, and their products are classified under FDA categories II and U.

Which regulatory registries or databases list Apatech Ltd’s devices?

Apatech Ltd’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone FDA review and received clearance or authorisation for commercial distribution in the US.

How are Apatech Ltd’s devices classified by the FDA?

Apatech Ltd’s devices fall under two primary FDA classifications: Class II and Class U. Class II devices generally require special controls to ensure safety and effectiveness, while Class U (Unclassified) devices are those that do not yet have a classification but are being reviewed for regulatory pathways like 510(k) clearance.

What is the primary purpose of Apatech Ltd’s bone matrix implants and bone wax?

Apatech Ltd’s bone matrix implants and bone wax are designed to aid in bone healing and filling defects during surgical procedures. The synthetic bone grafts (e.g., Actifuse variants) provide structural support to promote regeneration, while the bone wax (e.g., ALTAPORE) is used to seal bone surfaces and control bleeding. Most formulations are non-antimicrobial, though some variants include antimicrobial properties for specific clinical needs.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Website
baxter.com
Phone
+1(800)933-0303
DUNS number
221517829