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Orthalign, Inc.

United States·US-MF-000027362

Last updated September 17, 2026

Information

Country: United States
Address: 153, Technology, Irvine, United States
Website: www.orthalign.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 949.715.2424
PRRC Contact: Karyl Haskell
EUDAMED SRN: US-MF-000027362
FDA FEI Number: 3007521480
DUNS Number: 023266163

Catalogue (373)

Page 7 of 8

Device	Model / Reference	Registries	Class	Status
KneeAlign 2	402103	FDA UDI	Class II	Active
Lantern Surgical Assistant	402528-07	FDA UDI	Class II	Active
Lantern Surgical Assistant	402509	FDA UDI	Class II	Active
Lantern Surgical Assistant	402543	FDA UDI	Class II	Active
Lantern Surgical Assistant	402541	FDA UDI	Class II	Active
Lantern Surgical Assistant	402510	FDA UDI	Class II	Active
Lantern Surgical Assistant	402528-08	FDA UDI	Class II	Active
Kneealign System With Reference Sensor	K093998	FDA 510(k)	Class II	Active
OrthAlign Plus System	K200642	FDA 510(k)	Class II	Active
Lantern® Hip	K242616	FDA 510(k)	Class II	Active
OrthAlign Plus System	K162962	FDA 510(k)	Class II	Active
Harvey(R) Surgical Assistant	K200892	FDA 510(k)	Class II	Active
Orthalign Plus System	K140331	FDA 510(k)	Class II	Active
Orthoalign Plus System	K130387	FDA 510(k)	Class II	Active
Kneealign System	K103829	FDA 510(k)	Class II	Active
OrthAlign Plus System	K172462	FDA 510(k)	Class II	Active
OrthAlign Plus System	K171780	FDA 510(k)	Class II	Active
OrthAlign Plus System	K153237	FDA 510(k)	Class II	Active
KneeAlign 2 System	K163379	FDA 510(k)	Class II	Active
Kneealign System	K091411	FDA 510(k)	Class II	Active
KneeAlign 2	401592	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401571	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402045	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403001-07	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403430-07	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403101	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403307	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401572	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403430-01	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403001-08	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403370	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401639	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403029	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403469	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401579	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401612	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401645	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	403189	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	401596	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402069	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403376	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403430-04	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402042	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403317-090	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402418	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403114	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	133632	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402046	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403087-06	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401644	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (2)

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
Feb 10, 2026	Z-1630-2026	—	open, classified	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Feb 10, 2026	Z-1629-2026	—	open, classified	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)