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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 18 of 171

Device	Model / Reference	Registries	Class	Status
Pillar Sa	49-8218	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1035	FDA UDI	Class I	Active
Lonestar	83-8221	FDA UDI	Class I	Active
Proview	70-1324	FDA UDI	Class I	Active
Skyhawk	27-3148	FDA UDI	Class II	Active
Lonestar	83-8420	FDA UDI	Class I	Active
Forza	89-7012SP	FDA UDI	Class II	Active
Phoenix	20-4120	FDA UDI	Class II	Active
Firebird Sfs	77-7535	FDA UDI	Class II	Active
Navigated Instruments	36-1196	FDA UDI	Class I	Active
Firebird Sfs	77-7795	FDA UDI	Class II	Active
Lonestar	83-5307	FDA UDI	Class II	Active
Firebird	77-8480	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3570	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1240	FDA UDI	Class I	Active
Construx - Peek Vbr	48-1914	FDA UDI	Class I	Active
Construx - Mini Peek Vbr;construx - Mini Ptc	47-9004	FDA UDI	Class I	Active
Pillar Pl	46-1030	FDA UDI	Class I	Active
Janus	36-1227	FDA UDI	Class I	Active
Miscellaneous	46-1021	FDA UDI	Class I	Active
Forza	89-1016SP	FDA UDI	Class II	Active
Sfs	57-3030	FDA UDI	Class II	Active
Construx - Peek Vbr	45-0093	FDA UDI	Class I	Active
Phoenix	20-4035	FDA UDI	Class II	Active
Newbridge	40-3206	FDA UDI	Class II	Active
Quadrx	71-0110B	FDA UDI	Class I	Active
Sfs	55-1035	FDA UDI	Class I	Active
Pillar Sa	49-1001	FDA UDI	Class I	Active
Skyhawk	27-4443	FDA UDI	Class II	Active
Firebird	44-5535	FDA UDI	Class II	Active
Spinal-Stim	2212A	FDA UDI	Class III	Active
Skyhawk	27-2475	FDA UDI	Class II	Active
Firebird Nxg	36-8322	FDA UDI	Class I	Active
Firebird Nxg	36-8308	FDA UDI	Class I	Active
Skyhawk	27-4448	FDA UDI	Class II	Active
Construx - Mini Ptc	37-4109SP	FDA UDI	Class II	Active
Firebird Sfs	90-7604	FDA UDI	Class I	Active
Firebird SFS	77-8055	FDA UDI	Class II	Active
Cetra	19-6513	FDA UDI	Class II	Active
Fenestrated Screws	36-4855	FDA UDI	Class II	Active
Centurion	69-2030	FDA UDI	Class II	Active
Skyhawk	27-5233	FDA UDI	Class I	Active
Sfs	55-1057	FDA UDI	Class I	Active
Pillar Xl	73-2413	FDA UDI	Class II	Active
Phoenix Sfs	20-0283	FDA UDI	Class I	Active
Icon	68-7000	FDA UDI	Class II	Unknown
Skyhawk	27-5114	FDA UDI	Class I	Active
Skyhawk	27-1212	FDA UDI	Class II	Active
Skyhawk	27-3380	FDA UDI	Class II	Active
Skyhawk	27-2112	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.