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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 14 of 171

Device	Model / Reference	Registries	Class	Status
Skyhawk	27-2180	FDA UDI	Class II	Active
Sfs	59-1091	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-4675	FDA UDI	Class II	Active
Pillar Tl	45-7214	FDA UDI	Class II	Active
Firebird Sfs;icon Sfs	44-1065	FDA UDI	Class I	Active
Construx - Peek Vbr	48-1816	FDA UDI	Class I	Active
Ascent Le	66-3132	FDA UDI	Class II	Active
Firebird	51-7032	FDA UDI	Class II	Active
Cervical-Stim	2505D	FDA UDI	Class III	Active
Lonestar	83-8124	FDA UDI	Class I	Active
Pillar Xl	72-1218	FDA UDI	Class I	Active
Firebird	51-3660	FDA UDI	Class II	Active
Proview	70-2215	FDA UDI	Class I	Active
Cetra	19-2007	FDA UDI	Class I	Active
Reliant	64-6340	FDA UDI	Class II	Active
Ascent Le	66-3724	FDA UDI	Class II	Active
Unity	43-7530	FDA UDI	Class II	Active
Sfs	55-1150	FDA UDI	Class I	Active
Firebird	77-8755 BE	FDA UDI	Class II	Active
Firebird Sfs	51-0580	FDA UDI	Class I	Active
Skyhawk	27-3642	FDA UDI	Class II	Active
Firebird	52-6060	FDA UDI	Class II	Active
Firebird	77-8611	FDA UDI	Class II	Active
Construx -peek Vbr	47-3012C	FDA UDI	Class II	Active
Firebird	44-3710	FDA UDI	Class II	Active
Skyhawk	27-3170	FDA UDI	Class II	Active
Skyhawk	27-3616	FDA UDI	Class II	Active
Pillar Sa Ptc	39-2012SP	FDA UDI	Class II	Active
Skyhawk	27-5416	FDA UDI	Class I	Active
Firebird	52-2200	FDA UDI	Class II	Active
Forza	87-4612SP	FDA UDI	Class II	Active
Firebird	44-7835	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-3114	FDA UDI	Class II	Active
Firebird	44-5835	FDA UDI	Class II	Active
Forza	87-4408SP	FDA UDI	Class II	Active
Centurion	69-0112	FDA UDI	Class II	Active
Lonestar	83-5310	FDA UDI	Class II	Active
Skyhawk	27-4113	FDA UDI	Class II	Active
Pillar Xl	73-8410	FDA UDI	Class II	Active
Ascent	65-3422	FDA UDI	Class II	Active
Ascent Le	66-3632	FDA UDI	Class II	Active
Firebird Sfs	77-8135	FDA UDI	Class II	Active
Centurion	450419-0001	FDA UDI	Class I	Active
Forza	89-0155	FDA UDI	Class I	Active
Pillar Xl	72-1911	FDA UDI	Class I	Active
Pillar Xl	73-5120	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3845	FDA UDI	Class II	Active
Pillar Xl	72-5115	FDA UDI	Class II	Active
Ascent Le	66-3138	FDA UDI	Class II	Active
Sfs	61-8350	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.