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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 6 of 31

Device	Model / Reference	Registries	Class	Status
LineSider	LS-SC7G9545	FDA UDI	Class II	Active
LineSider	LS-N6RE6560	FDA UDI	Class II	Active
LineSider	LS-N6MG6560	FDA UDI	Class II	Active
FlareHawk	II-1-0237	FDA UDI	Class II	Unknown
LineSider	LS-N6MA5025	FDA UDI	Class II	Active
FlareHawk	FHTPCT0030TT	FDA UDI	Class II	Active
LineSider	LS-N6RE5545	FDA UDI	Class II	Active
LineSider	LS-N6MG6545	FDA UDI	Class II	Active
LineSider	LS-RD60C130	FDA UDI	Class II	Active
FlareHawk	CMP-00830	FDA UDI	Class II	Active
Accelus Navigated Reusable Instruments	ASY-00754	FDA UDI	Class II	Active
LineSider	LS-N6RG5055	FDA UDI	Class II	Active
LineSider	LS-N6MG4545	FDA UDI	Class II	Active
LineSider	LS-N6SA7530	FDA UDI	Class II	Active
LineSider	LS-RD55F030	FDA UDI	Class II	Active
FlareHawk	II-1-0114	FDA UDI	Class II	Unknown
LineSider	LS-N6ME4545	FDA UDI	Class II	Active
FlareHawk	CMP-00820	FDA UDI	Class II	Active
LineSider	LS-N6MA5035	FDA UDI	Class II	Active
FlareHawk	FHTAS10623O	FDA UDI	Class II	Active
LineSider	LS-SC7G8550	FDA UDI	Class II	Active
LineSider	LS-SC7G8590	FDA UDI	Class II	Active
LineSider	LS-N6SG9545	FDA UDI	Class II	Active
LineSider	LS-N6MG8555	FDA UDI	Class II	Active
FlareHawk	FHPAS300259S	FDA UDI	Class II	Active
LineSider	LS-SC7L6560	FDA UDI	Class II	Active
LineSider	LS-SC7E6555	FDA UDI	Class II	Active
LineSider	LS-N6RG9560	FDA UDI	Class II	Active
LineSider	LS-SC7R1570	FDA UDI	Class II	Active
LineSider	LS-SC7A7530	FDA UDI	Class II	Active
FlareHawk	II-1-0246	FDA UDI	Class II	Unknown
FlareHawk	FHTPS200307S	FDA UDI	Class II	Active
LineSider	LS-N6RA7540	FDA UDI	Class II	Active
LineSider	LS-RD55C070	FDA UDI	Class II	Active
LineSider	LS-RD55C040	FDA UDI	Class II	Active
FlareHawk	FHTPS206307S	FDA UDI	Class II	Active
FlareHawk	FHTPCS0030TT	FDA UDI	Class II	Active
LineSider	LS-RD60D200	FDA UDI	Class II	Active
LineSider	LS-IC55T25	FDA UDI	Class II	Active
LineSider	LS-N6ME5025	FDA UDI	Class II	Active
LineSider	LS-N6SR8590	FDA UDI	Class II	Active
LineSider	LS-N6RE7555	FDA UDI	Class II	Active
LineSider	LS-RD60D090	FDA UDI	Class II	Active
LineSider	LS-SC7L4520	FDA UDI	Class II	Active
LineSider	LS-RD60D065	FDA UDI	Class II	Active
LineSider	LS-N6MA5555	FDA UDI	Class II	Active
LineSider	LS-RD60D045	FDA UDI	Class II	Active
LineSider	LS-SC7R9590	FDA UDI	Class II	Active
LineSider	LS-RD60D500	FDA UDI	Class II	Active
LineSider	LS-N6MA1555	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.