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Integrity Implants Inc.

United States·US-MF-000009805

Last updated May 24, 2026

What Integrity Implants Inc. makes

Integrity Implants Inc. manufactures spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymer-based interbody fusion cages, reusable bone taps, and spinal fixation rods and connectors. Their product line also includes reusable surgical screwdrivers designed for spinal procedures.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

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 Integrity Implants Inc. manufacture?

Integrity Implants Inc. specializes in spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymer-based spinal interbody fusion cages, reusable bone taps, and components for internal spinal fixation systems like rods and connectors. Their product line also includes reusable surgical screwdrivers tailored for spinal surgical procedures. These devices are designed to support spinal stability and fusion.

Where is Integrity Implants Inc. based?

Integrity Implants Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as it operates under the jurisdiction of the FDA, which governs medical device authorization in the US.

Which regulatory registries list devices manufactured by Integrity Implants Inc.?

Devices from Integrity Implants Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, ensuring traceability and transparency in regulatory tracking. This listing helps healthcare providers and regulators verify device details.

How are devices from Integrity Implants Inc. classified under FDA regulations?

Integrity Implants Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny applied to each device type.

What is the purpose of the reusable bone taps and surgical screwdrivers produced by Integrity Implants Inc.?

The reusable bone taps and surgical screwdrivers from Integrity Implants Inc. are designed to assist in spinal surgical procedures. Bone taps create precise channels in vertebrae for screws or implants, while the screwdrivers provide controlled insertion or removal of spinal fixation hardware. Their reusable design aims to enhance efficiency and reduce waste in operating environments.

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

Information

Country: United States
Address: 354, Hiatt Drive, Palm Beach Gardens, United States
Website: www.accelusinc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 561 529 3861
PRRC Contact: Natalia Giaquinta
EUDAMED SRN: US-MF-000009805
FDA FEI Number: —
DUNS Number: 080300717

Catalogue (1530)

Page 27 of 31

Device	Model / Reference	Registries	Class	Status
FlareHawk Interbody Fusion System	CMP-00516	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00121	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00473	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTAS20027X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	FHPAS20623X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00402	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS30030S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	FHTAS30027X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00422	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00517	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0322	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00690	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00430	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Instrument Case Base	ASY-00484	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00078	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00432	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00308	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00317	EUDAMEDFDA UDI	Class I	Active
General Instrument Tray, FlareHawk7	ASY-00415	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0401	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00426	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPKW1	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0001	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTAS30627X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	II-1-0316	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0324	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00564	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0431	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPGP1A	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00518	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00132	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTAS10627X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00390	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS50030S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	II-1-0315	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0276	EUDAMEDFDA UDI	Class I	Active
MIS Disc Prep Set Tray Insert - Top	ASY-00525	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS40030S	EUDAMEDFDA UDI	Class IIb	Active
Open Disc Prep Tray - Top	ASY-00438	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0314	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0434	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00547	EUDAMEDFDA UDI	Class I	Active
Fixed Small Teardrop Handle	CMP-01024	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPCT0026C	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00154	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0396	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00133	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00702	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0325	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00455	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Integrity Implants Inc. has six FDA recall records initiated between February 27, 2018, and December 20, 2024. The records include instances of potential weld separation in components (noted in two records), a field correction for discrepancies in cleaning parameters in labeling material, and a compatibility issue between specific bone tamp and bone funnel revisions. The recall statuses listed are open, classified, and terminated.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 20, 2024	Z-1008-2025	—	open, classified	Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Aug 3, 2022	Z-0421-2023	—	terminated	Potential for intraoperative screw head separation at weld location.
Jan 27, 2022	Z-0418-2023	—	terminated	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Jan 27, 2022	Z-0420-2023	—	terminated	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Jan 27, 2022	Z-0419-2023	—	terminated	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Feb 27, 2018	Z-0405-2019	—	terminated	Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.