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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 8 of 171

Device	Model / Reference	Registries	Class	Status
Janus	36-2760	FDA UDI	Class II	Active
Ascent Le	66-3824	FDA UDI	Class II	Active
Proview	70-4106	FDA UDI	Class I	Active
Forza	89-0345	FDA UDI	Class I	Active
Spinal-Stim	2212D	FDA UDI	Class II	Active
Forza Ptc	38-4510SP	FDA UDI	Class II	Active
Ascent	65-3426	FDA UDI	Class II	Active
Lonestar	83-7606	FDA UDI	Class II	Active
Skyhawk	27-4179	FDA UDI	Class II	Active
Forza	89-0341	FDA UDI	Class I	Active
Unity	43-4023	FDA UDI	Class II	Active
Reliant	64-6580	FDA UDI	Class II	Active
Firebird	51-3411	FDA UDI	Class II	Active
Forza	89-9814SP	FDA UDI	Class II	Active
Forza	89-7714SP	FDA UDI	Class II	Active
Firebird Nxg	36-1071	FDA UDI	Class I	Active
Newbridge	40-2707	FDA UDI	Class II	Active
Forza	89-1709SP	FDA UDI	Class II	Active
Skyhawk	27-4477	FDA UDI	Class II	Active
Firebird	44-5625	FDA UDI	Class II	Active
Skyhawk	27-3508	FDA UDI	Class II	Active
Pemf - Physio-Stim	655314-0002	FDA UDI	Class III	Active
Firebird Sfs	450280-0006	FDA UDI	Class I	Active
Forza	89-0208	FDA UDI	Class I	Active
Skyhawk	27-5432	FDA UDI	Class I	Active
Ngage	76-1214	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3740	FDA UDI	Class II	Active
Skyhawk	27-3406	FDA UDI	Class II	Active
Lonestar	83-9746	FDA UDI	Class I	Active
Forza Ptc	38-4512SP	FDA UDI	Class II	Active
Ascent Le	66-3118	FDA UDI	Class II	Active
Pemf - Physio-Stim	655314-0004	FDA UDI	Class III	Active
Firebird	51-3565	FDA UDI	Class II	Active
Pillar Tl	45-7211	FDA UDI	Class II	Active
Skyhawk	27-1373	FDA UDI	Class II	Active
Firebird	77-8425	FDA UDI	Class II	Active
Pillar Xl	72-4216	FDA UDI	Class I	Active
Proview	70-3220	FDA UDI	Class I	Active
Pillar Xl	72-1214	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	56-3840	FDA UDI	Class II	Active
Firebird	44-3575	FDA UDI	Class II	Active
Forza	89-7715SP	FDA UDI	Class II	Active
Firebird Sfs	90-7574	FDA UDI	Class I	Active
Icon	54-3425	FDA UDI	Class II	Active
Hallmark	62-6700	FDA UDI	Class II	Active
Skyhawk	27-5534	FDA UDI	Class I	Active
Miscellaneous	20123806	FDA UDI	Class I	Active
Construx - Mini Ptc	47-6008	FDA UDI	Class I	Active
Ngage	450259-0001	FDA UDI	Class II	Active
Firebird	52-6035	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.