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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 16 of 171

Device	Model / Reference	Registries	Class	Status
Construx - Mini Ptc	37-4007SP	FDA UDI	Class II	Active
Ascent	65-3410	FDA UDI	Class II	Active
Navigated Instruments;phoenix Sfs	20-1226	FDA UDI	Class II	Active
Firebird Sfs	51-7100	FDA UDI	Class I	Active
Construx - Peek Vbr	45-3213	FDA UDI	Class II	Active
Skyhawk	27-1380	FDA UDI	Class II	Active
Forza	89-7510SP	FDA UDI	Class II	Active
Skyhawk	27-1578	FDA UDI	Class II	Active
Skyhawk	27-1119	FDA UDI	Class II	Active
Forza Ptc	38-9014SP	FDA UDI	Class II	Active
Firebird SFS	77-8080	FDA UDI	Class II	Active
Pillar Sa	49-1005	FDA UDI	Class I	Active
Construx - Peek Vbr	45-2251	FDA UDI	Class II	Active
Hallmark	62-6784	FDA UDI	Class II	Active
Firebird	61-7345	FDA UDI	Class II	Active
Centurion	69-0070	FDA UDI	Class II	Active
Forza	89-0306	FDA UDI	Class I	Active
Pillar Xl	72-2214	FDA UDI	Class II	Active
Newbridge	40-1005	FDA UDI	Class I	Active
Forza	89-7415SP	FDA UDI	Class II	Active
Construx - Peek Vbr	450203-0001	FDA UDI	Class II	Active
Firebird	44-5555 BE	FDA UDI	Class II	Active
Skyhawk	27-4612	FDA UDI	Class II	Active
Construx - Mini Ptc	37-5908	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	55-4840	FDA UDI	Class II	Active
Ascent Le	66-3230	FDA UDI	Class II	Active
Pillar Tl	46-1046	FDA UDI	Class I	Active
Construx - Mini Ptc	37-5909	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	56-3435	FDA UDI	Class II	Active
Skyhawk	27-3647	FDA UDI	Class II	Active
Firebird	44-3080	FDA UDI	Class II	Active
Skyhawk	27-1674	FDA UDI	Class II	Active
Skyhawk	27-3273	FDA UDI	Class II	Active
Skyhawk	27-2641	FDA UDI	Class II	Active
Firebird	44-5695 BE	FDA UDI	Class II	Active
Forza	87-7412SP	FDA UDI	Class II	Active
Firebird	51-4475	FDA UDI	Class II	Active
Skyhawk	27-4473	FDA UDI	Class II	Active
Skyhawk	27-2318	FDA UDI	Class II	Active
Firebird Nxg	36-0090	FDA UDI	Class I	Active
Firebird	77-7790	FDA UDI	Class II	Active
Construx - Peek Vbr	45-1045	FDA UDI	Class I	Active
Cetra	19-0358	FDA UDI	Class II	Active
Pillar Tl	46-1014	FDA UDI	Class I	Active
Centurion	69-1012	FDA UDI	Class I	Active
Centurion	69-3228	FDA UDI	Class II	Active
Skyhawk	27-5833	FDA UDI	Class I	Active
Forza Ptc	38-1011SP	FDA UDI	Class II	Active
Construx - Peek Vbr	45-3311	FDA UDI	Class II	Active
Sfs	55-1048	FDA UDI	Class I	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.