Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030409224

FEI Number

3030409224

Entity Name

ENHATCH, INC

City/State/Country

Hasbrouck Heights, NJ, US

Establishment Address

411 State Rt 17 Ste 500, Hasbrouck Heights, NJ 07604, US

Establishment Type(s)

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

Owner / Operator

Enhatch, Inc (Owner Number: 10089831)

Owner / Operator Contact Address

411 State Route 117, Suite 500, Hasbrouck Heights, NJ 07604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230850

PMA Number

N/A

All Registered Proprietary Names

United Orthopedic Knee Patient Specific Instrumentation Intelligent Surgery Knee

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2024-01-11
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2024-01-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-01-11

Official Correspondent

Monica Williams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Enhatch, 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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3003998208	MATERIALISE N.V.	LEUVEN Vlaams Brabant, BE
9617840	ZIMMER CAS	MONTREAL, QUEBEC, CA
3011724582	Materialise Colombia S.A.S	Medellin Antioquia, CO
3004153240	ConforMIS, Inc.	Wilmington, MA, US
3005718816	Materialise USA, LLC.	Plymouth, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030409224. Last updated year: 2026. Please use registration number 3030409224 when referencing this establishment in official correspondence.