Is this your brand? Sign in to claim ownership.

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 12 of 171

Device	Model / Reference	Registries	Class	Status
Pillar Xl	73-1519	FDA UDI	Class I	Active
Navigated Instruments;firebird Nxg	36-1313	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3840	FDA UDI	Class II	Active
Skyhawk	27-5337	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	56-3670	FDA UDI	Class II	Active
Firebird	51-6530	FDA UDI	Class II	Active
Firebird Sfs	52-1390	FDA UDI	Class I	Active
Pillar Pl	45-6407	FDA UDI	Class II	Active
Sfs	57-0001	FDA UDI	Class I	Active
Forza	89-9709SP	FDA UDI	Class II	Active
Construx - Peek Vbr	45-2231	FDA UDI	Class II	Active
Firebird Sfs	90-7603	FDA UDI	Class I	Active
Centurion	69-3140	FDA UDI	Class II	Active
Firebird Sfs	450392-0001	FDA UDI	Class I	Active
Pillar Xl	73-5210	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	58-3545	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3725	FDA UDI	Class II	Active
Pillar Xl	72-1317	FDA UDI	Class I	Active
Pillar Xl	73-2115	FDA UDI	Class II	Active
Fenestrated Screws	36-5430SP	FDA UDI	Class II	Active
Lonestar	84-7613	FDA UDI	Class II	Active
Forza	89-7809SP	FDA UDI	Class II	Active
Firebird	44-3340	FDA UDI	Class II	Active
Cetra	19-0370	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-4013	FDA UDI	Class II	Active
Forza Ptc	38-1010SP	FDA UDI	Class II	Active
Firebird	77-7755	FDA UDI	Class II	Active
Firebird	44-5675	FDA UDI	Class II	Active
Firebird	77-8670 BE	FDA UDI	Class II	Active
Skyhawk	27-2447	FDA UDI	Class II	Active
Forza	88-9911SP	FDA UDI	Class II	Active
Firebird	44-7575	FDA UDI	Class II	Active
Firebird	77-7530	FDA UDI	Class II	Active
Firebird	44-7355	FDA UDI	Class II	Active
Cetra	19-5520	FDA UDI	Class II	Active
Ascent Le	66-3542	FDA UDI	Class II	Active
Forza Ptc	38-4210SP	FDA UDI	Class II	Active
3 Degree	60-0047	FDA UDI	Class I	Active
Skyhawk	27-3277	FDA UDI	Class II	Active
Skyhawk	27-4239	FDA UDI	Class II	Active
Skyhawk	27-2238	FDA UDI	Class II	Active
Skyhawk	27-3347	FDA UDI	Class II	Active
Forza	89-0114	FDA UDI	Class I	Active
Lonestar	83-9741	FDA UDI	Class I	Active
Pillar Xl	72-0091	FDA UDI	Class I	Active
Skyhawk	27-1543	FDA UDI	Class II	Active
Skyhawk	27-2549	FDA UDI	Class II	Active
Navigated Instruments;firebird Nxg	36-1321	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3640	FDA UDI	Class II	Active
Firebird Sfs	44-3050	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.