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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 6 of 171

Device	Model / Reference	Registries	Class	Status
Firebird Nxg	450451-0004	FDA UDI	Class I	Active
Firebird	44-7750	FDA UDI	Class II	Active
Firebird Sfs	44-3195	FDA UDI	Class II	Active
Cetra	19-4516	FDA UDI	Class II	Active
Firebird Sfs	90-6474	FDA UDI	Class I	Active
Pillar Sa	49-2112	FDA UDI	Class II	Active
Sfs	55-6202	FDA UDI	Class II	Active
Construx - Peek Vbr	45-2246	FDA UDI	Class II	Active
Lonestar	83-5507	FDA UDI	Class II	Active
Firebird Sfs	450321-0001	FDA UDI	Class I	Active
Pillar Xl	73-8114	FDA UDI	Class II	Active
Pillar Xl	73-2216	FDA UDI	Class II	Active
Ascent;ascent Le;centurion	65-1082	FDA UDI	Class II	Active
Pillar Sa	49-3114	FDA UDI	Class I	Active
Hallmark	62-6950	FDA UDI	Class II	Active
Hallmark	62-0036	FDA UDI	Class I	Active
Pillar Sa	49-1214	FDA UDI	Class I	Active
Firebird	61-7840	FDA UDI	Class II	Active
Forza Xp	28-3180	FDA UDI	Class II	Active
Sfs	55-6005	FDA UDI	Class II	Active
Construx - Peek Vbr	48-1218	FDA UDI	Class I	Active
Firebird	77-8765 BE	FDA UDI	Class II	Active
Icon	54-3650	FDA UDI	Class II	Active
Firebird Sfs	77-8850	FDA UDI	Class II	Active
Pillar Sa	49-5530	FDA UDI	Class II	Active
Firebird SFS	77-8190	FDA UDI	Class II	Active
Pillar Sa	49-8312	FDA UDI	Class I	Active
Forza	89-2016SP	FDA UDI	Class II	Active
Firebird	61-7675	FDA UDI	Class II	Active
Forza	89-3010SP	FDA UDI	Class II	Active
Connector	79-8302	FDA UDI	Class I	Active
Firebird	51-4670	FDA UDI	Class II	Active
Firebird	44-7860	FDA UDI	Class II	Active
Forza	87-7411SP	FDA UDI	Class II	Active
Unity	43-1023	FDA UDI	Class II	Active
Firebird	61-7860	FDA UDI	Class II	Active
Firebird	52-6120	FDA UDI	Class II	Active
Lonestar	84-7408	FDA UDI	Class II	Active
Firebird	51-3680	FDA UDI	Class II	Active
Pillar Sa	49-6218	FDA UDI	Class II	Active
3 Degree	60-0046	FDA UDI	Class I	Active
Construx -peek Vbr	47-3011C	FDA UDI	Class II	Active
Navigated Instruments;phoenix Sfs	20-1227	FDA UDI	Class II	Active
Forza	89-0259	FDA UDI	Class I	Active
Skyhawk	27-2349	FDA UDI	Class II	Active
Pillar Tl	45-7411	FDA UDI	Class II	Active
Sfs	450237-0001	FDA UDI	Class I	Active
Proview	70-2219	FDA UDI	Class I	Active
Ngage	74-1630	FDA UDI	Class II	Active
Skyhawk	27-1375	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.