Romd L L C

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008959459
• FEI Number: 3008959459
• Name: ROMD, LLC
• Owner & Operator: Royal Oak Medical Devices
• Contact Address: 2967 Waterview Drive ; Rochester Hills MI 48309 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2967 Waterview Drive ; Rochester Hills, MI 48309 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K110046 | NKB ROMD, LLC [Royal Oak Medical Devices]	VTI InterLink? Pedicle Screw System	2011-12-30
PMN K110046 | NKB ROMD, LLC [Royal Oak Medical Devices]	Royal Oak Pedicle Screw System	2011-12-30
PMN K110046 | NKB ROMD, LLC [Royal Oak Medical Devices]	Athena Pedicle Screw System	2011-12-30
PMN K110046 | NKB ROMD, LLC [Royal Oak Medical Devices]	Agoge Pedicle Screw System	2011-12-30
PMN K110046 | MNI ROMD, LLC [Royal Oak Medical Devices]	VTI InterLink? Pedicle Screw System	2011-12-30
PMN K110046 | MNI ROMD, LLC [Royal Oak Medical Devices]	Royal Oak Pedicle Screw System	2011-12-30
PMN K110046 | MNI ROMD, LLC [Royal Oak Medical Devices]	Athena Pedicle Screw System	2011-12-30
PMN K110046 | MNI ROMD, LLC [Royal Oak Medical Devices]	Agoge Pedicle Screw System	2011-12-30
PMN K110046 | MNH ROMD, LLC [Royal Oak Medical Devices]	VTI InterLink? Pedicle Screw System	2011-12-30
PMN K110046 | MNH ROMD, LLC [Royal Oak Medical Devices]	Royal Oak Pedicle Screw System	2011-12-30
PMN K110046 | MNH ROMD, LLC [Royal Oak Medical Devices]	Athena Pedicle Screw System	2011-12-30
PMN K110046 | MNH ROMD, LLC [Royal Oak Medical Devices]	Agoge Pedicle Screw System	2011-12-30
PMN K110177 | MAX ROMD, LLC [Royal Oak Medical Devices]	Royal Oak IBFD System	2011-06-03
PMN K110177 | MAX ROMD, LLC [Royal Oak Medical Devices]	Hippeis IBFD System	2011-06-03
PMN K110177 | MAX ROMD, LLC [Royal Oak Medical Devices]	Helena IBFD System	2011-06-03