Is this your brand? Sign in to claim ownership.

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 26 of 31

Device	Model / Reference	Registries	Class	Status
LineSider	LS-RD60D060	FDA UDI	Class II	Active
LineSider	LS-SC7G6555	FDA UDI	Class II	Active
LineSider	LS-N6SA6545	FDA UDI	Class II	Active
FlareHawk	II-1-0128	FDA UDI	Class II	Active
LineSider	LS-RD55A075	FDA UDI	Class II	Active
FlareHawk	II-1-0239	FDA UDI	Class II	Unknown
LineSider	LS-N6RA7530	FDA UDI	Class II	Active
LineSider	LS-N6RG1540	FDA UDI	Class II	Active
FlareHawk	FHPAS200259S	FDA UDI	Class II	Active
LineSider	LS-SC7G8545	FDA UDI	Class II	Active
LineSider	LS-N6SG5060	FDA UDI	Class II	Active
LineSider	LS-N6SE7530	FDA UDI	Class II	Active
LineSider	LS-N6MG6540	FDA UDI	Class II	Active
Accelus Navigated Reusable Instruments	ASY-00742	FDA UDI	Class II	Active
LineSider	LS-N6SA1550	FDA UDI	Class II	Active
LineSider	LS-RD55D600	FDA UDI	Class II	Active
Accelus Navigated Reusable Instruments	ASY-00751	FDA UDI	Class II	Active
Accelus Navigated Reusable Instruments	ASY-00802	FDA UDI	Class II	Active
Expandable Trial Insert Tray, FH7	ASY-00653	EUDAMEDFDA UDI	Class I	Active
Backup Fixed T-Handle	II-1-0372	EUDAMEDFDA UDI	Class I	Active
Dilator Impactor, FH7 MIS	CMP-00480	EUDAMEDFDA UDI	Class I	Active
Open Disc Prep Tray - Bottom	ASY-00437	EUDAMEDFDA UDI	Class I	Active
LineSider™ Spinal System	K203367	FDA 510(k)	Class II	Active
Toro-L Interbody Fusion System	K203038	FDA 510(k)	Class II	Active
Integrity Implants Navigated Instruments	K212088	FDA 510(k)	Class II	Active
LineSider® Spinal System	K231098	FDA 510(k)	Class II	Active
Toro-L Interbody Fusion System	K213355	FDA 510(k)	Class II	Active
FlareHawk TiHawk9 Interbody Fusion System	K201367	FDA 510(k)	Class II	Active
LineSider™ Spinal System	K190360	FDA 510(k)	Class II	Active
FlareHawk Interbody Fusion System	ASY-00459	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS20630S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	CMP-00535	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0015	EUDAMEDFDA UDI	Class I	Active
Ancillary Instrument Tray, FH7	ASY-00523	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Universal Instrument Tray	ASY-00489	EUDAMEDFDA UDI	Class I	Active
MIS Disc Prep Tray, FH7	ASY-00521	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS30626S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	FHTAS10027X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00408	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0475	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0361	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00695	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00316	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00513	EUDAMEDFDA UDI	Class I	Active
Impact Cap	II-1-0045	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0476	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0309	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0036	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPCS0030C	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	CMP-00693	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.