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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 9 of 171

Device	Model / Reference	Registries	Class	Status
Construx - Peek Vbr	48-1620	FDA UDI	Class I	Active
Pemf - Spinal-Stim	655212-0003	FDA UDI	Class III	Active
Phoenix Sfs	90-7964	FDA UDI	Class I	Active
Skyhawk	27-3516	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1051	FDA UDI	Class I	Active
Firebird Sfs	51-8080	FDA UDI	Class II	Active
Centurion	69-0043	FDA UDI	Class I	Active
Construx - Mini Peek Vbr	47-3113C	FDA UDI	Class II	Active
Forza	87-4316SP	FDA UDI	Class II	Active
Skyhawk	27-4610	FDA UDI	Class II	Active
Pillar Tl	46-1611	FDA UDI	Class I	Active
Pillar Sa	49-1043	FDA UDI	Class I	Active
Cetra	19-7017	FDA UDI	Class II	Active
Construx - Mini Ptc	37-5906	FDA UDI	Class I	Active
Firebird	44-3611	FDA UDI	Class II	Active
Skyhawk	27-3246	FDA UDI	Class II	Active
Pillar Xl	450279-0001	FDA UDI	Class II	Active
Skyhawk	27-3313	FDA UDI	Class II	Active
Skyhawk	27-2214	FDA UDI	Class II	Active
Forza Xp	28-2242	FDA UDI	Class II	Active
Pillar Sa	49-5525	FDA UDI	Class II	Active
Pillar Sa	49-9712	FDA UDI	Class I	Active
Firebird	44-5530	FDA UDI	Class II	Active
Firebird	77-7595	FDA UDI	Class II	Active
Phoenix	20-7200	FDA UDI	Class II	Active
Lonestar	83-5411	FDA UDI	Class II	Active
Pillar Xl	72-2109	FDA UDI	Class II	Active
Samba Screw	11-1109-FD19A	FDA UDI	Class I	Active
Pemf - Physio-Stim	655313-0002	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1241	FDA UDI	Class I	Active
Forza	87-1412SP	FDA UDI	Class II	Active
Pillar Xl	72-2110	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3745	FDA UDI	Class II	Active
Sfs	55-5225	FDA UDI	Class II	Active
Skyhawk	27-3643	FDA UDI	Class II	Active
Forza Xp	28-1023	FDA UDI	Class I	Active
Ascent	65-1002	FDA UDI	Class I	Active
Pillar Al	48-3214	FDA UDI	Class II	Active
Firebird	44-2103	FDA UDI	Class II	Active
Ascent	65-1043	FDA UDI	Class I	Active
Phoenix Sfs	20-0330	FDA UDI	Class I	Active
Firebird Sfs	90-7571	FDA UDI	Class I	Active
Pillar Al	48-4020	FDA UDI	Class II	Active
Skyhawk	27-2109	FDA UDI	Class II	Active
Firebird	55-5325	FDA UDI	Class II	Active
Skyhawk	27-4344	FDA UDI	Class II	Active
Connector	79-8304	FDA UDI	Class I	Active
Ascent	65-1048	FDA UDI	Class I	Active
Construx - Peek Vbr	48-1510	FDA UDI	Class I	Active
Ascent Le	66-3322	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.