Pathfinder NXT Minimally Invasive Pedicle Screw System

Advanced Fixed Bar, 10 Implants, ZrO2/TAN

Registry build 21.09.26
2manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code EHO
Manufacturer City Province Registered as Device types
Foshan Nanhai Hongchen Medical Equipments Co., Ltd. Foshan Guangdong Manufacturer 11
Zhuhai DS Dental Technology Co., Ltd. Zhuhai Guangdong Manufacturer 8

Record

Regulatory record for Pathfinder NXT Minimally Invasive Pedicle Screw System
Listed by Institut Straumann AG, Switzerland
FDA product code EHO
Device type Bar, Preformed
Device class Class 1
Regulation 21 CFR 872.3165
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2019-08-24
Record revised 2023-01-17 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries serial number
Distribution end date 2026-01-20

Catalogue Numbers

Catalogue numbers for Pathfinder NXT Minimally Invasive Pedicle Screw System
Catalogue number Size Status
Bridges (implant borne) In distribution
Screws In distribution
Bridges (implant borne) In distribution
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Bridges (implant borne) In distribution
Bridges (implant borne) In distribution
Bridges (implant borne) In distribution
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Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Preat Preat Corporation 61
remanium® Dentaurum GmbH & Co. KG 23
Bar, Preformed Dentaurum GmbH & Co. KG 14
Bar, Preformed Stryker Leibinger Gmbh & Co. KG 6
Nobil Metal SPA Nobil Metal SPA 6
Hader Bar Preat Corporation 6
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 3
Bar, Preformed Institut Straumann AG 2
V. Mueller Steris Corporation 1
Hader Preat Corporation 1
Universal IC Attachment Preat Corporation 1
Millennium Avalign Technologies, Inc. 1

Showing 12 of 15. All products under Bar, Preformed

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer