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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 1 of 171

Device	Model / Reference	Registries	Class	Status
Firebird	44-5950 AF	FDA UDI	Class II	Active
Firebird	44-5790	FDA UDI	Class II	Active
Skyhawk	27-4339	FDA UDI	Class II	Active
Firebird Nxg	450465-0001	FDA UDI	Class I	Active
Firebird Nxg	36-8311	FDA UDI	Class I	Active
Firebird	51-4440	FDA UDI	Class II	Active
Skyhawk	27-2443	FDA UDI	Class II	Active
Skyhawk	27-2209	FDA UDI	Class II	Active
Skyhawk	27-2314	FDA UDI	Class II	Active
Centurion	69-1031	FDA UDI	Class I	Active
Janus	36-2730	FDA UDI	Class II	Active
Centurion	69-3535	FDA UDI	Class II	Active
Firebird Sfs	61-2093	FDA UDI	Class I	Active
Firebird	44-5710	FDA UDI	Class II	Active
Phoenix Sfs	20-0311	FDA UDI	Class I	Active
Construx - Peek Vbr	48-1320	FDA UDI	Class I	Active
Firebird	52-6070	FDA UDI	Class II	Active
Pillar Xl	72-8208	FDA UDI	Class II	Active
Firebird Sfs	44-0012	FDA UDI	Class I	Active
Firebird	51-4610	FDA UDI	Class II	Active
Firebird Nxg	36-6801	FDA UDI	Class II	Active
Miscellaneous	46-1024	FDA UDI	Class I	Active
Firebird	77-7855	FDA UDI	Class II	Active
Cetra	19-8013	FDA UDI	Class II	Active
Firebird	52-2050	FDA UDI	Class II	Active
Forza	89-9409SP	FDA UDI	Class II	Active
Pillar Sa	49-1102	FDA UDI	Class I	Active
Construx - Mini Peek Vbr	47-4005	FDA UDI	Class II	Active
Janus	450461-0001	FDA UDI	Class I	Active
Centurion	69-3620	FDA UDI	Class II	Active
Centurion	69-3418	FDA UDI	Class II	Active
Lonestar	83-8340	FDA UDI	Class I	Active
Skyhawk	27-1645	FDA UDI	Class II	Active
Skyhawk	27-1417	FDA UDI	Class II	Active
Forza	89-0213	FDA UDI	Class I	Active
Skyhawk	24-5630	FDA UDI	Class II	Active
Firebird Sfs	77-7811	FDA UDI	Class II	Active
Fenestrated Screws	36-4530	FDA UDI	Class II	Active
Skyhawk	27-5712	FDA UDI	Class I	Active
Ascent Le	450286-0001	FDA UDI	Class I	Active
Firebird	44-7470	FDA UDI	Class II	Active
Pillar Sa	49-6212	FDA UDI	Class II	Active
Pemf - Physio-Stim	655314-0102	FDA UDI	Class II	Active
Fenestrated Screws	36-4960	FDA UDI	Class II	Active
Skyhawk	27-1312	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4825	FDA UDI	Class II	Active
Skyhawk	27-2308	FDA UDI	Class II	Active
Phoenix	20-5450	FDA UDI	Class II	Active
Pillar Xl	73-5108	FDA UDI	Class II	Active
Ngage	76-1209	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.