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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 28 of 31

Device	Model / Reference	Registries	Class	Status
Open Disc Prep Tray	ASY-00436	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS30630S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00006	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00406	EUDAMEDFDA UDI	Class I	Active
0 Degree Shaver and Distractor Tray	ASY-00419	EUDAMEDFDA UDI	Class I	Active
Depth Stop, FH7	ASY-00903	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00534	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS50026S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00571	EUDAMEDFDA UDI	Class I	Active
Inline Handle, Mini AO, FH7	ASY-00569	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0326	EUDAMEDFDA UDI	Class I	Active
Implant Tray, FlareHawk7	ASY-00370	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0310	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00113	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPCT0030C	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	II-1-0042	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00450	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00502	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00768	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS10626S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	II-1-0435	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01040	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00474	EUDAMEDFDA UDI	Class I	Active
Integrity Implants Universal Lid	ASY-00410	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00688	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00377	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01189	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00391	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00434	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00431	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0313	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0038	EUDAMEDFDA UDI	Class I	Active
MIS Disc Prep Set Tray Insert - Bottom	ASY-00527	EUDAMEDFDA UDI	Class I	Active
MIS Instrument Case, FH7	ASY-00480	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00510	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00704	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01188	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00425	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00448	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00008	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00692	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00584	EUDAMEDFDA UDI	Class I	Active
MIS Access Tray, FH7	ASY-00582	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00409	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00475	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00392	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00457	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS20030S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	FHPACT0923H	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00476	EUDAMEDFDA UDI	Class I	Active

Related Companies

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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.