Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018759542

FEI Number

3018759542

Entity Name

DIMENSION ORTHO Inc.

City/State/Country

Philadelphia, PA, US

Establishment Address

2275 Bridge St Bldg 208 Ste 320, Philadelphia, PA 19137, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Dimension Ortho Inc. (Owner Number: 10081609)

Owner / Operator Contact Address

2275 Bridge Street, Building 208, Suite 320, Philadelphia, PA 19137, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DimensionCast

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2021-04-28

Official Correspondent

Steven Stubitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dimension Ortho Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3023346034	COMEBETTER (GUANGZHOU) TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
3029961128	GERO3D LTD	Tel Aviv-Yafo Central, IL
3043047582	OY PRIMO FINLAND AB	Vaasa Pohjanmaa, FI
3009605026	JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.	Yancheng Jiangsu, CN
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018759542. Last updated year: 2026. Please use registration number 3018759542 when referencing this establishment in official correspondence.