Spinemed Ges M B H

FDA Filings

This page includes the latest FDA filings for Spinemed Ges 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: 3014942696
• FEI Number: 3014942696
• Name: Acron Medical, LLC
• Owner & Operator: spineMED Ges.m.b.H
• Contact Address: Twarochgasse 11 ; Vienna AT-9 Wien 1170 AT
• Official Correspondent:
  • Carolyn Guthrie
  • 43-1-4799281-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1800 Pembrook Dr Suite 300; Orlando, FL 32810 US

• Registration Number: 3012296146
• FEI Number: 3012296146
• Name: Mike Burgan
• Owner & Operator: spineMED Ges.m.b.H
• Contact Address: Twarochgasse 11 ; Vienna AT-9 Wien 1170 AT
• Official Correspondent:
  • Carolyn Guthrie
  • 43-1-4799281-x
• US Agent:
  • Mike Burgan
  • Kapstone Medical LLC
  • 704 8437852
  • mburgan@kapstonemedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5960 Fairview Rd, #400 ; Charlotte, NC 28210 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K171151 | MAX Mike Burgan [spineMED Ges.m.b.H]	ACRON? T-LIF System	2018-11-12
PMN K171151 SpineMED Ges.m.b.H	ACRON™ TLIF System	2018-04-27