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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 11 of 171

Device	Model / Reference	Registries	Class	Status
Skyhawk	27-5512	FDA UDI	Class I	Active
Skyhawk	27-4413	FDA UDI	Class II	Active
Forza	89-6012SP	FDA UDI	Class II	Active
Cetra	19-7013	FDA UDI	Class II	Active
Skyhawk	27-4439	FDA UDI	Class II	Active
Skyhawk	27-4218	FDA UDI	Class II	Active
Skyhawk	27-4209	FDA UDI	Class II	Active
Firebird	44-5490	FDA UDI	Class II	Active
Pillar Tl	45-7412	FDA UDI	Class II	Active
Skyhawk	27-3177	FDA UDI	Class II	Active
Skyhawk	27-1178	FDA UDI	Class II	Active
Navigated Instruments;firebird Nxg	36-1339	FDA UDI	Class II	Active
Firebird SFS	77-8945	FDA UDI	Class II	Active
Pillar Xl	73-1517	FDA UDI	Class I	Active
Reliant	64-6640	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	55-4770	FDA UDI	Class II	Active
Skyhawk	27-2580	FDA UDI	Class II	Active
Pillar Pl	450210-0001	FDA UDI	Class II	Active
Forza Xp	450703-0001	FDA UDI	Class II	Active
Pemf - Spinal-Stim	655212-0005	FDA UDI	Class II	Active
Skyhawk	27-1412	FDA UDI	Class II	Active
Pillar Tl	45-7316	FDA UDI	Class II	Active
Pillar Xl	72-3000	FDA UDI	Class I	Active
Centurion	69-3645	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3850	FDA UDI	Class II	Active
Firebird	44-3435	FDA UDI	Class II	Active
Skyhawk	27-4513	FDA UDI	Class II	Active
Ascent Le	66-3544	FDA UDI	Class II	Active
Skyhawk	27-5834	FDA UDI	Class I	Active
Sfs	57-3051	FDA UDI	Class II	Active
Pillar Sa	49-8120	FDA UDI	Class I	Active
Lonestar	83-8647	FDA UDI	Class I	Active
Skyhawk	27-1478	FDA UDI	Class II	Active
Skyhawk	27-2171	FDA UDI	Class II	Active
Skyhawk	27-4616	FDA UDI	Class II	Active
Firebird	44-3695	FDA UDI	Class II	Active
Centurion	69-1049	FDA UDI	Class I	Active
Centurion	69-1092	FDA UDI	Class I	Active
Pillar Pl	45-6416	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1094	FDA UDI	Class I	Active
Ascent Le	66-3730	FDA UDI	Class II	Active
Pillar Xl	72-5210	FDA UDI	Class II	Active
Proview	70-1406	FDA UDI	Class I	Active
Skyhawk	26-1020	FDA UDI	Class I	Active
Skyhawk	27-4670	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4840	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4670	FDA UDI	Class II	Active
Lonestar	83-8427	FDA UDI	Class I	Active
Centurion	69-3635	FDA UDI	Class II	Active
Skyhawk	26-1040	FDA UDI	Class I	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.