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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 7 of 171

Device	Model / Reference	Registries	Class	Status
Janus	36-2650	FDA UDI	Class II	Active
Proview	70-4201	FDA UDI	Class I	Active
Skyhawk	26-1314	FDA UDI	Class I	Active
Proview	70-1142	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	59-3530	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4465	FDA UDI	Class II	Active
Firebird Sfs	52-1930	FDA UDI	Class I	Active
Pillar Xl	73-8112	FDA UDI	Class II	Active
Ngage	74-1209	FDA UDI	Class II	Active
Firebird	51-6535	FDA UDI	Class II	Active
Ngage	76-6017	FDA UDI	Class II	Active
Forza	89-9414SP	FDA UDI	Class II	Active
Firebird	51-3640	FDA UDI	Class II	Active
Pillar Sa	49-5120	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-3110	FDA UDI	Class II	Active
Centurion	69-3530	FDA UDI	Class II	Active
Ngage	74-0020	FDA UDI	Class I	Active
Lonestar	83-9004	FDA UDI	Class I	Active
Ascent Le	66-3810	FDA UDI	Class II	Active
Firebird	44-3170	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4570	FDA UDI	Class II	Active
Firebird	51-3485	FDA UDI	Class II	Active
Skyhawk	27-4478	FDA UDI	Class II	Active
Firebird	77-7695	FDA UDI	Class II	Active
Proview	70-3221	FDA UDI	Class I	Active
Pillar Sa	49-7212	FDA UDI	Class II	Active
Skyhawk	27-2340	FDA UDI	Class II	Active
Firebird Nxg	36-8321	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2341	FDA UDI	Class II	Active
Firebird	44-3311	FDA UDI	Class II	Active
Ascent Le	66-3348	FDA UDI	Class II	Active
Firebird Sfs	52-1591	FDA UDI	Class I	Active
Firebird	52-2090	FDA UDI	Class II	Active
Skyhawk	27-2345	FDA UDI	Class II	Active
Pillar Xl	72-5217	FDA UDI	Class II	Active
Pillar Xl	73-8416	FDA UDI	Class II	Active
Pillar Sa	450265-0001	FDA UDI	Class I	Active
Pillar Xl	72-4013	FDA UDI	Class I	Active
Forza	87-1212SP	FDA UDI	Class II	Active
Pillar Pl	45-6616	FDA UDI	Class II	Active
Ascent	65-3322	FDA UDI	Class II	Active
Ascent Le	65-6425	FDA UDI	Class II	Active
Firebird Sfs	450322-0001	FDA UDI	Class I	Active
Forza Xp	450481-0002	FDA UDI	Class II	Active
Phoenix Sfs	20-0320	FDA UDI	Class I	Active
Firebird Sfs	44-3035	FDA UDI	Class II	Active
Pillar Al	48-4010	FDA UDI	Class II	Active
Forza	89-4514SP	FDA UDI	Class II	Active
Forza	88-2011SP	FDA UDI	Class II	Active
Hallmark	62-3100	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.