Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007521480

FEI Number

3007521480

Entity Name

OrthAlign, Inc.

City/State/Country

Irvine, CA, US

Establishment Address

153 Technology, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

OrthAlign, Inc (Owner Number: 10028839)

Owner / Operator Contact Address

153 Technology, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153237

PMA Number

N/A

All Registered Proprietary Names

Surgical Instrument - Cutting Reference Sensor Lantern HIp Reference Sensor Lantern Hip Navigation Unit Lantern Hip Femur Sensor Lantern Hip Instrument Set OPU w leg length and offset RS4 Lantern ASC Smart Pack Kit Lantern ASC Navigation Unit Lantern Knee Navigation System Lantern Knee Instrument Set Lantern Reference Sensor HipAlign initial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2009-03-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-11-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-12-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-09-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-03-23
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2024-12-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-03-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2011-11-30
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2026-06-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-07-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2010-01-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-12-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-09-09

Official Correspondent

Karyl Haskell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthAlign, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

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1822565	ZIMMER, INC.	WARSAW, IN, US
8010877	KOSCHER & WUERTZ GMBH	SPAICHINGEN Baden-Wurttemberg, DE
8040172	BURAQ SURGICAL CORP.	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007521480. Last updated year: 2026. Please use registration number 3007521480 when referencing this establishment in official correspondence.