Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008125983

FEI Number

3008125983

Entity Name

Penn United Technologies, Inc.

City/State/Country

Warminster, PA, US

Establishment Address

1756 Stout Dr, PO 2926, Warminster, PA 18974, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Penn United Technologies, Inc. (Owner Number: 10044967)

Owner / Operator Contact Address

1756 Stout Drive, PO 2926, Warminster, PA 18974, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110998

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-09-03
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2013-09-03

Official Correspondent

David Delaney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Penn United Technologies, 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008125983. Last updated year: 2026. Please use registration number 3008125983 when referencing this establishment in official correspondence.