Scopis G M B H

FDA Filings

This page includes the latest FDA filings for Scopis G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011043662
• FEI Number: 3011043662
• Name: SCOPIS GMBH
• Owner & Operator: STRYKER CORP.
• Contact Address: 1901 Romence Pkwy ; Portage MI 49002 US
• US Agent:
  • Jody Powell
  • Stryker Instruments
  • 269 3237700 3718
  • jody.powell@stryker.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Heinrich-Heine-Platz 10 ; Berlin Berlin, 10179 DE
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID B057U9020010 Scopis GmbH	Patient tracker tabs (PU 100) U9 020 01	2019-10-23
GUDID B057U1017050 Scopis GmbH	Instrument clamp 10-16 mm U1 017 05	2018-10-22
GUDID B057U1017030 Scopis GmbH	Instrument clamp 6-10 mm U1 017 03	2018-10-22
GUDID B057U1017020 Scopis GmbH	Instrument clamp forceps U1 017 02	2018-10-22
GUDID B057U1017010 Scopis GmbH	Instrument clamp 2-6 mm U1 017 01	2018-10-22
GUDID B057U4003260170 Scopis GmbH	NOVA AR U4 003	2018-07-31
GUDID B057U40140 Scopis GmbH	NOVA Basic U4 014	2018-03-29
GUDID B057U4003260160 Scopis GmbH	NOVA AR U4 003	2018-03-29
GUDID B057U40030 Scopis GmbH	NOVA AR U4 003	2018-03-29
GUDID B057U3011010 Scopis GmbH	Field generator mounting arm U3 011 01	2018-03-29
GUDID B057U3010010 Scopis GmbH	Field generator planar U3 010 01	2018-03-29
GUDID B057U2040040 Scopis GmbH	Hybrid Navigation Unit EM U2 040 04	2018-03-29
GUDID B057U1085400 Scopis GmbH	Instrument clip 4 mm U1 085 40	2018-03-29
GUDID B057U1049010 Scopis GmbH	Instrument port U1 049 01	2018-03-29
GUDID B057U1046020 Scopis GmbH	Universal Tracker EM U1 046 02	2018-03-29
GUDID B057U1038020 Scopis GmbH	Calibration body EM U1 038 02	2018-03-29
GUDID B057U1037020 Scopis GmbH	Endoscope tracker EM U1 037 02	2018-03-29
GUDID B057U1031300 Scopis GmbH	Patient tracker EM-D mini U1 031 30	2018-03-29
GUDID B057U1031120 Scopis GmbH	Patient tracker EM mini U1 031 12	2018-03-29
GUDID B057U1030120 Scopis GmbH	Suction tube Eicken EM U1 030 12	2018-03-29
GUDID B057U1030110 Scopis GmbH	Suction tube Frazier EM U1 030 11	2018-03-29
GUDID B057U1029030 Scopis GmbH	Registration pointer EM-D U1 029 03	2018-03-29
GUDID B057U1029010 Scopis GmbH	Precision Pointer EM U1 029 01	2018-03-29
PMN K171661 Scopis GmbH	Scopis Extended Instrument Set EM	2017-09-27
PMN K161491 Scopis GmbH	Scopis Hybrid Navigation System EM	2017-02-09