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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 3 of 171

Device	Model / Reference	Registries	Class	Status
Firebird	44-5845 BE	FDA UDI	Class II	Active
Skyhawk	24-8102	FDA UDI	Class I	Active
Phoenix Sfs	90-7330	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-4430	FDA UDI	Class II	Active
Firebird Sfs	52-1765	FDA UDI	Class I	Active
Construx - Peek Vbr	45-0090	FDA UDI	Class I	Active
Ascent Le	66-2070	FDA UDI	Class II	Active
Pillar Xl	73-1214	FDA UDI	Class I	Active
Proview	70-3100	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-4525	FDA UDI	Class II	Active
SambaScrew	11-1109-2	FDA UDI	Class II	Active
Pillar Xl	73-1310	FDA UDI	Class I	Active
Hallmark	62-4140	FDA UDI	Class II	Active
Forza Xp	28-3240	FDA UDI	Class II	Active
Construx - Peek Vbr	48-1220	FDA UDI	Class I	Active
Lonestar	83-5314	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4780	FDA UDI	Class II	Active
Firebird	44-5645 BE	FDA UDI	Class II	Active
Firebird	44-5711	FDA UDI	Class II	Active
Newbridge	40-1002	FDA UDI	Class I	Active
Forza	89-4309SP	FDA UDI	Class II	Active
Firebird	44-5011 AF	FDA UDI	Class II	Active
Firebird	44-7565	FDA UDI	Class II	Active
Forza	89-9611SP	FDA UDI	Class II	Active
Cetra	19-3020	FDA UDI	Class II	Active
Skyhawk	27-3318	FDA UDI	Class II	Active
Skyhawk	27-1608	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3740	FDA UDI	Class II	Active
Skyhawk	27-4442	FDA UDI	Class II	Active
Firebird	77-8875	FDA UDI	Class II	Active
Proview	70-1091	FDA UDI	Class I	Active
Firebird	44-7890	FDA UDI	Class II	Active
Firebird	44-5465	FDA UDI	Class II	Active
Firebird	44-3475	FDA UDI	Class II	Active
Lonestar	83-9522	FDA UDI	Class I	Active
Lonestar	83-9347	FDA UDI	Class I	Active
Skyhawk	27-1316	FDA UDI	Class II	Active
Firebird Sfs	77-8965	FDA UDI	Class II	Active
Skyhawk	27-4614	FDA UDI	Class II	Active
Firebird	77-8570	FDA UDI	Class II	Active
Lonestar	84-5613	FDA UDI	Class II	Active
Fenestrated Screws	36-4955	FDA UDI	Class II	Active
Forza	89-0156	FDA UDI	Class I	Active
Firebird Sfs	52-1093	FDA UDI	Class I	Active
Ascent Le	65-2200	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-3009	FDA UDI	Class II	Active
Pillar Tl	45-1022	FDA UDI	Class I	Active
Pillar Xl	73-2119	FDA UDI	Class II	Active
Forza	89-7411SP	FDA UDI	Class II	Active
Firebird	77-8655 BE	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.