Imascap

FDA Filings

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

FDA Registration(s)

• Registration Number: 3014027736
• FEI Number: 3014027736
• Name: IMASCAP
• Owner & Operator: Tornier Inc.
• Contact Address: 10801 Nesbitt Avenue South --; Bloomington MN 55437 US
• Official Correspondent:
  • Kris Tucker
  • x-952-9217138-x
• US Agent:
  • Kevin Smith
  • 952 9217121
  • kevin.smith@wright.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 65 place Nicolas Copernic ; PLOUZANE Finistere, 29280 FR
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K162800 | KWS IMASCAP [Tornier Inc.]	BLUEPRINT Patient Specific Instrumentation	2017-03-22
PMN K161789 | KWS IMASCAP [Tornier Inc.]	BluePrint	2017-01-04
PMN K160555 | KWS IMASCAP [Tornier Inc.]	BLUEPRINT Patient Specific Instrumentation	2016-06-23
PMN K143374 | KWS IMASCAP [Tornier Inc.]	BLUEPRINT Patient Specific Instrumentation	2016-01-14