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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 7 of 31

Device	Model / Reference	Registries	Class	Status
LineSider	LS-N6RG1560	FDA UDI	Class II	Active
LineSider	LS-SC7A5535	FDA UDI	Class II	Active
LineSider	LS-N6SG1555	FDA UDI	Class II	Active
LineSider	LS-N6ME5520	FDA UDI	Class II	Active
FlareHawk	II-1-0175	FDA UDI	Class II	Unknown
Accelus Navigated Reusable Instruments	ASY-00744	FDA UDI	Class II	Active
LineSider	LS-N6MA8545	FDA UDI	Class II	Active
LineSider	LS-SC7G5040	FDA UDI	Class II	Active
LineSider	LS-SC7L7525	FDA UDI	Class II	Active
LineSider	LS-N6RE5035	FDA UDI	Class II	Active
LineSider	LS-N6SA7540	FDA UDI	Class II	Active
FlareHawk	FHTPS100307S	FDA UDI	Class II	Active
LineSider	ASY-00713	FDA UDI	Class II	Active
LineSider	LS-SC7G6525	FDA UDI	Class II	Active
FlareHawk	FHTACT0929TT	FDA UDI	Class II	Active
LineSider	LS-N6MA7550	FDA UDI	Class II	Active
LineSider	LS-N6SE5530	FDA UDI	Class II	Active
LineSider	LS-N6RA4555	FDA UDI	Class II	Active
LineSider	LS-IC55T20	FDA UDI	Class II	Active
LineSider	LS-N6MA5060	FDA UDI	Class II	Active
LineSider	LS-SC7L5520	FDA UDI	Class II	Active
LineSider	LS-SC7L5560	FDA UDI	Class II	Active
FlareHawk	CMP-00821	FDA UDI	Class II	Active
LineSider	LS-RD55F090	FDA UDI	Class II	Active
LineSider	LS-SC7L4550	FDA UDI	Class II	Active
LineSider	LS-SC7G5035	FDA UDI	Class II	Active
SightLine	SL-155	FDA UDI	Class I	Active
LineSider	LS-N6SR1510	FDA UDI	Class II	Active
FlareHawk	CMP-00111	FDA UDI	Class II	Active
FlareHawk	FHPAS100259S	FDA UDI	Class II	Active
LineSider	LS-RD55B045	FDA UDI	Class II	Active
LineSider	LS-N6ME5535	FDA UDI	Class II	Active
LineSider	LS-SC7G5530	FDA UDI	Class II	Active
LineSider	LS-SC7G4535	FDA UDI	Class II	Active
LineSider	LS-SC7L5535	FDA UDI	Class II	Active
LineSider	ASY-01127	FDA UDI	Class II	Active
FlareHawk	II-1-0447	FDA UDI	Class II	Active
LineSider	LS-SC7R8520	FDA UDI	Class II	Active
LineSider	LS-RD60C075	FDA UDI	Class II	Active
FlareHawk	FHPACS0025TTS	FDA UDI	Class II	Active
LineSider	LS-N6RE4545	FDA UDI	Class II	Active
LineSider	LS-RD55B130	FDA UDI	Class II	Active
Accelus Navigated Reusable Instruments	ASY-00732	FDA UDI	Class II	Active
LineSider	LS-N6MG5525	FDA UDI	Class II	Active
LineSider	LS-SC7L5060	FDA UDI	Class II	Active
FlareHawk	II-1-0185	FDA UDI	Class II	Active
LineSider	LS-N6SR8510	FDA UDI	Class II	Active
LineSider	LS-N6SA5535	FDA UDI	Class II	Active
FlareHawk	FHTGCT0929TTS	FDA UDI	Class II	Active
LineSider	LS-SC7L6535	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.