FDA Registration
Active
🇺🇸 United States
OrthAlign, Inc.
Reg #: 3007521480
·
FEI: 3007521480
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- OrthAlign, Inc.
- Registration Number
- 3007521480
- FEI Number
- 3007521480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 153 Technology
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172462
Owner / Operator
- Firm Name
- OrthAlign, Inc
- Operator Number
- 10028839
- Address
- 153 Technology
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Karyl Haskell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2009-03-11 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-11-27 |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2024-12-11 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-05-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-04-08 |
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
Instrument
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility