Otn Implants B V

FDA Filings

This page includes the latest FDA filings for Otn Implants B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015679904
• FEI Number: 3015679904
• Name: OTN Implants B.V.
• Owner & Operator: OTN Implants B.V.
• Contact Address: Simon Stevinweg 48 ; Arnhem NL-GE Gelderland 6827BT NL
• Official Correspondent:
  • Pamela C Musch
  • 31-26-7370371-x
• US Agent:
  • Fred Hernandez
  • AMPUTEK, INC.
  • 155 9676678
  • fred@osseotek.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Simon Stevinweg 48 ; Arnhem Gelderland, 6827BT NL
• Establishment Type:
  • Manufacture Medical Device
  • Foreign Private Label Distributor

FDA Filings

Device Company	Device	Date
MDM OTN Implants B.V.	OTNI Surgical Instrument set - Basic	2019-08-16
IRD OTN Implants B.V.	OTNI Heli male/female osseointegration connector with offset plate	2019-08-16
HTQ OTN Implants B.V.	OTNI Surgical Instrument set - Curved Rasps	2019-08-16
HTO OTN Implants B.V.	OTNI Surgical Instrument Set - Rigid Reamers	2019-08-16