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Integrity Implants Inc.

United States·US-MF-000009805

Last updated May 24, 2026

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 31 of 31

Device	Model / Reference	Registries	Class	Status
FlareHawk Interbody Fusion System	FHPACT0023SB	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk9 25mm Implant Caddy	CMP-00708	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Insertion Instrument Tray	ASY-00485	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00456	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00443	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS20026S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	FHTAS20627X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk9 Gun Inserter Tray Insert	ASY-01017	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00701	EUDAMEDFDA UDI	Class I	Active
MIS Disc Prep Set Base	ASY-00524	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00449	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00435	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00428	EUDAMEDFDA UDI	Class I	Active
Slap Hammer	II-1-0005	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00427	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00399	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPCS0026C	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	CMP-01202	EUDAMEDFDA UDI	Class I	Active
9° and 15° Distractor Tray	ASY-00420	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 29mm Implant Caddy	CMP-00587	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHGPGUN	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01984	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHPAS30623X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00116	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00538	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00446	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00841	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Implant Case	II-1-0145	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00337	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Gun Inserter Instrument Tray Base	ASY-01016	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.

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.