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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 17 of 171

Device	Model / Reference	Registries	Class	Status
Ngage	76-1710	FDA UDI	Class II	Active
Forza Xp	28-1012	FDA UDI	Class I	Active
Firebird	51-3665	FDA UDI	Class II	Active
Pillar Sa	49-0716	FDA UDI	Class I	Active
Forza	89-7514SP	FDA UDI	Class II	Active
Pillar Xl	72-5411	FDA UDI	Class II	Active
Proview	90-2125	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2346	FDA UDI	Class II	Active
Pillar Tl	46-1102	FDA UDI	Class I	Active
Lonestar	84-7507	FDA UDI	Class II	Active
Forza	89-4512SP	FDA UDI	Class II	Active
Firebird SFS	51-8072	FDA UDI	Class II	Active
Firebird	77-7840	FDA UDI	Class II	Active
Pillar Xl	72-4120	FDA UDI	Class I	Active
Pillar Xl	72-0090	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-4760	FDA UDI	Class II	Active
Skyhawk	27-5230	FDA UDI	Class I	Active
Ascent	65-3316	FDA UDI	Class II	Active
Firebird Sfs	52-1102	FDA UDI	Class I	Active
Firebird	77-8780 BE	FDA UDI	Class II	Active
Ascent	65-1025	FDA UDI	Class I	Active
Cetra	19-9003	FDA UDI	Class I	Active
Pillar Xl	73-1610	FDA UDI	Class I	Active
Firebird Sfs	52-1228	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2508	FDA UDI	Class II	Active
Firebird Sfs	44-3870	FDA UDI	Class II	Active
Sfs	57-3011	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1095	FDA UDI	Class I	Active
Firebird Nxg	36-6417	FDA UDI	Class II	Active
Forza	87-9011SP	FDA UDI	Class II	Active
Pillar Pl	46-1033	FDA UDI	Class I	Active
Skyhawk	27-4108	FDA UDI	Class II	Active
Fenestrated Screws	36-4970	FDA UDI	Class II	Active
Hallmark	62-6200	FDA UDI	Class II	Active
Pillar Sa	49-1040	FDA UDI	Class I	Active
3 Degree;hallmark;reliant	60-0050	FDA UDI	Class I	Active
Firebird Nxg	450453-0003	FDA UDI	Class I	Active
3 Degree	60-1180	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	55-4730	FDA UDI	Class II	Active
Cetra	19-1004	FDA UDI	Class I	Active
Firebird Sfs	77-5645SP	FDA UDI	Class II	Active
Ascent Le	66-1090	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2356	FDA UDI	Class II	Active
Sfs	57-0011	FDA UDI	Class I	Active
Pillar Al	48-2012	FDA UDI	Class II	Active
Skyhawk	27-1348	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3770	FDA UDI	Class II	Active
Cetra	19-9030	FDA UDI	Class I	Active
Pillar Xl	73-1613	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2516	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.