Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042749512

FEI Number

3042749512

Entity Name

Orthios Office

City/State/Country

Kearny, NJ, US

Establishment Address

78 John Miller Way Ste 1018, Kearny, NJ 07032, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Orthios Innovations LLC (Owner Number: 10090945)

Owner / Operator Contact Address

7601 River Rd. Apt 727, North Bergen, NJ 07047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Weight Bear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-06-05

Official Correspondent

David Pancratz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthios Innovations LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042749512. Last updated year: 2026. Please use registration number 3042749512 when referencing this establishment in official correspondence.