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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 2 of 31

Device	Model / Reference	Registries	Class	Status
LineSider	LS-N6RA8545	FDA UDI	Class II	Active
LineSider	LS-N6ME5545	FDA UDI	Class II	Active
LineSider	LS-N6RG8540	FDA UDI	Class II	Active
LineSider	LS-TU7M5560	FDA UDI	Class II	Active
FlareHawk	FHTGS10625A	FDA UDI	Class II	Active
LineSider	LS-N6MA5535	FDA UDI	Class II	Active
LineSider	LS-SC7A6530	FDA UDI	Class II	Active
FlareHawk	FHTGS100251S	FDA UDI	Class II	Active
LineSider	LS-SC7A5045	FDA UDI	Class II	Active
LineSider	LS-SC7G6535	FDA UDI	Class II	Active
LineSider	LS-RD55A030	FDA UDI	Class II	Active
FlareHawk	FHTGS30625A	FDA UDI	Class II	Active
LineSider	LS-N6SE4520	FDA UDI	Class II	Active
LineSider	LS-N6SG4525	FDA UDI	Class II	Active
LineSider	LS-N6RA4530	FDA UDI	Class II	Active
LineSider	LS-RD55A035	FDA UDI	Class II	Active
LineSider	LS-SC7E5550	FDA UDI	Class II	Active
LineSider	LS-N6SG9540	FDA UDI	Class II	Active
LineSider	LS-N6SA5045	FDA UDI	Class II	Active
FlareHawk	FHTGS10029A	FDA UDI	Class II	Active
FlareHawk	FHPACT0025TT	FDA UDI	Class II	Active
LineSider	LS-AC5060A2	FDA UDI	Class II	Active
LineSider	LS-CL6-3338	FDA UDI	Class II	Unknown
LineSider	LS-RD60C080	FDA UDI	Class II	Active
FlareHawk	FHTGCT0929TT	FDA UDI	Class II	Active
LineSider	LS-N6SE5035	FDA UDI	Class II	Active
LineSider	LS-N6ME6545	FDA UDI	Class II	Active
LineSider	LS-RD50G600	FDA UDI	Class II	Unknown
LineSider	LS-N6RA7555	FDA UDI	Class II	Active
FlareHawk	FHTPS206267S	FDA UDI	Class II	Active
LineSider	LS-N6ME7530	FDA UDI	Class II	Active
FlareHawk	FHTAS100299S	FDA UDI	Class II	Active
FlareHawk	FHTPS306307S	FDA UDI	Class II	Active
FlareHawk	FHTGS30025A	FDA UDI	Class II	Active
LineSider	LS-AC6060A2	FDA UDI	Class II	Active
LineSider	LS-SC7A6550	FDA UDI	Class II	Active
LineSider	LS-N6SE5545	FDA UDI	Class II	Active
LineSider	LS-N6ME7540	FDA UDI	Class II	Active
LineSider	LS-SC7G5545	FDA UDI	Class II	Active
LineSider	LS-N6SR7580	FDA UDI	Class II	Active
LineSider	LS-N6CR8510	FDA UDI	Class II	Active
LineSider	LS-N6SE7540	FDA UDI	Class II	Active
LineSider	LS-RD55C055	FDA UDI	Class II	Active
LineSider	LS-RD55C045	FDA UDI	Class II	Active
LineSider	LS-N6SG5035	FDA UDI	Class II	Active
LineSider	LS-AC5050A1	FDA UDI	Class II	Active
LineSider	LS-N6SG9555	FDA UDI	Class II	Active
FlareHawk	II-1-0232	FDA UDI	Class II	Unknown
LineSider	LS-N6RA4535	FDA UDI	Class II	Active
LineSider	LS-SC7L4535	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.