Ortek Ag

FDA Filings

This page includes the latest FDA filings for Ortek Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003061090
• FEI Number: 3003061090
• Name: Jerry Doane
• Owner & Operator: ORTEK AG
• Contact Address: INDUSTRIE NORD 5 --; MERENSCHWAND CH-AG Aargau CH-5634 CH
• Official Correspondent:
  • HANS - BACHMANN
  • 41-566-755757-x
• US Agent:
  • Jerry Doane
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: FDAbasics LLC 15815 SW 11th Court Rd.; Ocala, FL 34473 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K131354 | KWY Jerry Doane [ORTEK AG]	RENOVIS BIPOLAR HIP SYSTEM	2013-11-13