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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 29 of 31

Device	Model / Reference	Registries	Class	Status
FlareHawk Interbody Fusion System	FHTPS10630S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	CMP-00077	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00696	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00873	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTAS40027X	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00418	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00405	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00514	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00372	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00869	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Ancillary Instrument Tray	ASY-00486	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00147	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01738	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00707	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00120	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00700	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00501	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00515	EUDAMEDFDA UDI	Class I	Active
Dilator Handle, FH7 MIS	ASY-00481	EUDAMEDFDA UDI	Class I	Active
Dilator Impactor, FH7 ENDO	CMP-01431	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00656	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTACS0027SB	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	CMP-00705	EUDAMEDFDA UDI	Class I	Active
Implant Caddy, 30L, FlareHawk7	ASY-00368	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	II-1-0321	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00407	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00532	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00723	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00145	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS20626S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00165	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00389	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00840	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00721	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHGP23	EUDAMEDFDA UDI	Class I	Active
FlareHawk9 Cannula and Obturator Tray	ASY-00499	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00533	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-01983	EUDAMEDFDA UDI	Class I	Active
Fixed Hudson T-Handle	II-1-0328	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00396	EUDAMEDFDA UDI	Class I	Active
ENDO Access Tray, FH7	ASY-00581	EUDAMEDFDA UDI	Class I	Active
Implant/Access Case, FH7	ASY-00579	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00698	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTPS30026S	EUDAMEDFDA UDI	Class IIb	Active
FlareHawk Interbody Fusion System	ASY-00122	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00417	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00483	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	ASY-00665	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	CMP-00512	EUDAMEDFDA UDI	Class I	Active
FlareHawk Interbody Fusion System	FHTA-GP-27-A	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.