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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 19 of 171

Device	Model / Reference	Registries	Class	Status
Forza	89-0407	FDA UDI	Class I	Active
Skyhawk	27-3270	FDA UDI	Class II	Active
Forza	87-8016SP	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	58-3440	FDA UDI	Class II	Active
Pillar Xl	72-2408	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	58-3565	FDA UDI	Class II	Active
Skyhawk	27-1344	FDA UDI	Class II	Active
Firebird SI Fusion	18-2040SP	FDA UDI	Class II	Active
Firebird	51-4470	FDA UDI	Class II	Active
Forza Ptc	38-1812SP	FDA UDI	Class II	Active
Pillar Xl	73-8217	FDA UDI	Class II	Active
Ascent	65-3309	FDA UDI	Class II	Active
Pillar Sa	49-8112	FDA UDI	Class I	Active
Firebird	44-5330	FDA UDI	Class II	Active
Skyhawk	27-4119	FDA UDI	Class II	Active
Physio-Stim	3314R	FDA UDI	Class III	Active
Forza	89-0456	FDA UDI	Class I	Active
Pillar Xl	72-4118	FDA UDI	Class I	Active
Pillar Xl	73-2318	FDA UDI	Class II	Active
Pillar Xl	73-1320	FDA UDI	Class I	Active
Firebird	77-7560	FDA UDI	Class II	Active
Firebird	44-3670	FDA UDI	Class II	Active
Firebird	44-5435	FDA UDI	Class II	Active
Skyhawk	27-4238	FDA UDI	Class II	Active
Firebird Sfs	77-8875	FDA UDI	Class II	Active
Firebird Nxg	36-8471	FDA UDI	Class I	Active
Skyhawk	27-4311	FDA UDI	Class II	Active
Construx - Mini Ptc	37-3007	FDA UDI	Class II	Active
Forza	89-0209	FDA UDI	Class I	Active
Firebird	44-5335	FDA UDI	Class II	Active
Skyhawk	26-1311	FDA UDI	Class I	Active
Firebird	44-5735 BE	FDA UDI	Class II	Active
Forza	89-4415SP	FDA UDI	Class II	Active
Pillar Tl	46-1006	FDA UDI	Class I	Active
Lonestar	83-9641	FDA UDI	Class I	Active
Firebird	44-5795 BE	FDA UDI	Class II	Active
Centurion	69-3452	FDA UDI	Class II	Active
Lonestar	83-8223	FDA UDI	Class I	Active
Proview	70-1342	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	56-3835	FDA UDI	Class II	Active
Fenestrated Screws	36-5945SP	FDA UDI	Class II	Active
Physio-Stim	3314L	FDA UDI	Class III	Active
Proview	70-1022	FDA UDI	Class I	Active
Firebird Sfs	77-8075	FDA UDI	Class II	Active
3 Degree	60-6844	FDA UDI	Class II	Active
Firebird	44-3430	FDA UDI	Class II	Active
Firebird	44-5375	FDA UDI	Class II	Active
Centurion	69-3318	FDA UDI	Class II	Active
3 Degree	60-6820	FDA UDI	Class II	Active
Pillar Xl	72-2219	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.