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Orthofix US LLC

Last updated September 17, 2026

Information

Country: US
Address: 3451 Plano Parkway, Lewisville, TX, 75056
Website: orthofix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)527-0404
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2183449
DUNS Number: 927083808

Catalogue (8519)

Page 15 of 171

Device	Model / Reference	Registries	Class	Status
Firebird	44-7610	FDA UDI	Class II	Active
Forza	87-7608SP	FDA UDI	Class II	Active
Lonestar	83-3818	FDA UDI	Class II	Active
Reliant	64-6660	FDA UDI	Class II	Active
Firebird Sfs	52-1005	FDA UDI	Class I	Active
Forza	89-1015SP	FDA UDI	Class II	Active
Firebird Nxg	36-8476	FDA UDI	Class I	Active
Construx - Mini Peek Vbr	47-3108	FDA UDI	Class II	Active
Firebird SFS	77-8111	FDA UDI	Class II	Active
Lonestar	83-8643	FDA UDI	Class I	Active
Lonestar	83-8220	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-3650	FDA UDI	Class II	Active
Skyhawk	27-4649	FDA UDI	Class II	Active
Skyhawk	27-4310	FDA UDI	Class II	Active
Firebird Sfs	52-1060	FDA UDI	Class I	Active
Orthofix Osteogenesis Stimulator	3314R	FDA UDI	Class III	Active
Phoenix Sfs	20-0381	FDA UDI	Class I	Active
Skyhawk	27-3271	FDA UDI	Class II	Active
Icon	54-3525	FDA UDI	Class II	Active
Firebird Sfs	51-1259	FDA UDI	Class I	Active
Forza	20113129	FDA UDI	Class I	Active
Forza	88-2008SP	FDA UDI	Class II	Active
Hallmark	62-6560	FDA UDI	Class II	Active
Firebird	44-3065	FDA UDI	Class II	Active
Cetra	19-4010	FDA UDI	Class II	Active
Forza	20113137	FDA UDI	Class I	Active
Forza Xp	28-1022	FDA UDI	Class I	Active
Hallmark	62-6724	FDA UDI	Class II	Active
Hallmark	62-6543	FDA UDI	Class II	Active
Skyhawk	24-5550	FDA UDI	Class II	Active
Firebird	44-5925 AF	FDA UDI	Class II	Active
Firebird	77-7630	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-1107	FDA UDI	Class I	Active
Firebird	77-7850	FDA UDI	Class II	Active
Skyhawk	27-4541	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-3107	FDA UDI	Class II	Active
Construx - Peek Vbr	48-1916	FDA UDI	Class I	Active
Forza	87-9009SP	FDA UDI	Class II	Active
Quadrx	71-3040	FDA UDI	Class I	Active
Pillar Sa Ptc	39-9018SP	FDA UDI	Class II	Active
Icon	54-3770	FDA UDI	Class II	Active
Pillar Al	48-2112	FDA UDI	Class II	Active
Firebird	51-3435	FDA UDI	Class II	Active
Skyhawk	27-4279	FDA UDI	Class II	Active
Forza	87-1409SP	FDA UDI	Class II	Active
Firebird	44-7595	FDA UDI	Class II	Active
Firebird	51-4555	FDA UDI	Class II	Active
Firebird	44-3610	FDA UDI	Class II	Active
Firebird Sfs	52-1590	FDA UDI	Class I	Active
Centurion	69-3448	FDA UDI	Class II	Active

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FDA Recalls (9)

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
Nov 3, 2025	Z-0896-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0893-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0895-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0894-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0891-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0892-2026	—	open, classified	Labeling contains claims that are not consistently present.
Sep 19, 2025	Z-0478-2026	—	open, classified	Polyaxial screws do not meet performance standards.
Jun 24, 2025	Z-2555-2025	—	open, classified	A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
Feb 20, 2025	Z-1432-2025	—	open, classified	The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.