Royal Oak Medical Devices

FDA Filings

This page includes the latest FDA filings for Royal Oak Medical Devices. 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 K110046 ROYAL OAK MEDICAL DEVICES	ATHENA PEDICLE SCREW SYSTEM	2011-12-07
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
PMN K110177 ROYAL OAK MEDICAL DEVICES	HELENA SYSTEM	2011-04-21

Similar & Related FDA Registered Companies

• Royal Oak Medical Devices LLC