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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 4 of 31

Device	Model / Reference	Registries	Class	Status
FlareHawk	II-1-0394	FDA UDI	Class II	Active
LineSider	LS-SC7E5540	FDA UDI	Class II	Active
LineSider	LS-SC7L7545	FDA UDI	Class II	Active
LineSider	LS-AC5060A1	FDA UDI	Class II	Active
LineSider	LS-RD55C120	FDA UDI	Class II	Active
FlareHawk	FHTGS400251S	FDA UDI	Class II	Active
LineSider	LS-SC7E5040	FDA UDI	Class II	Active
LineSider	LS-N6SG7545	FDA UDI	Class II	Active
LineSider	LS-SC7A7550	FDA UDI	Class II	Active
LineSider	LS-N6ME4530	FDA UDI	Class II	Active
LineSider	LS-RD55F120	FDA UDI	Class II	Active
LineSider	LS-N6MA5550	FDA UDI	Class II	Active
Toro-L	ASY-01042	FDA UDI	Class II	Active
FlareHawk	FHTGS106291S	FDA UDI	Class II	Active
LineSider	LS-N6MA4530	FDA UDI	Class II	Active
LineSider	LS-N6ME5045	FDA UDI	Class II	Active
LineSider	LS-N6CR1510	FDA UDI	Class II	Active
LineSider	LS-SC7R9500	FDA UDI	Class II	Active
FlareHawk	FHPACT0925PTS	FDA UDI	Class II	Active
LineSider	LS-N6RG4525	FDA UDI	Class II	Active
LineSider	LS-N6MG9555	FDA UDI	Class II	Active
LineSider	LS-RD50E055	FDA UDI	Class II	Unknown
LineSider	LS-N6SA6560	FDA UDI	Class II	Active
LineSider	LS-N6SE6530	FDA UDI	Class II	Active
LineSider	LS-N6ME7545	FDA UDI	Class II	Active
Toro-L	ASY-00591	FDA UDI	Class II	Active
FlareHawk	II-1-0387	FDA UDI	Class II	Active
LineSider	LS-AC6063B1	FDA UDI	Class II	Active
LineSider	LS-SS255560	FDA UDI	Class II	Active
LineSider	LS-N6SA6555	FDA UDI	Class II	Active
LineSider	LS-N6RG9550	FDA UDI	Class II	Active
LineSider	LS-N6SR9590	FDA UDI	Class II	Active
LineSider	LS-RD55A070	FDA UDI	Class II	Active
LineSider	LS-SC7L6520	FDA UDI	Class II	Active
LineSider	LS-RD55A040	FDA UDI	Class II	Active
LineSider	LS-RD55D090	FDA UDI	Class II	Active
LineSider	LS-SC7E4540	FDA UDI	Class II	Active
FlareHawk	ASY-00047	FDA UDI	Class II	Active
LineSider	LS-SC7R1580	FDA UDI	Class II	Active
LineSider	LS-N6RA5025	FDA UDI	Class II	Active
LineSider	LS-RD50G500	FDA UDI	Class II	Unknown
LineSider	LS-N6CR9520	FDA UDI	Class II	Active
LineSider	LS-SC7G7580	FDA UDI	Class II	Active
LineSider	LS-N6SG5560	FDA UDI	Class II	Active
LineSider	LS-RD50E070	FDA UDI	Class II	Unknown
LineSider	LS-SC7G5045	FDA UDI	Class II	Active
Toro-L	TL10-002455	FDA UDI	Class II	Active
LineSider	LS-N6MG7560	FDA UDI	Class II	Active
LineSider	LS-RD55D030	FDA UDI	Class II	Active
LineSider	LS-RD60D035	FDA UDI	Class II	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.