FDA.reportPublic FDA data

ROMD, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30089594593008959459ROMD, LLC1N2026-01-012967 Waterview Drive Rochester Hills MI US 48309

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812352020007Royal Oak Pedicle Screw System - Set Screw248-853-1450customerservice@royaloakmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1297941289298967K110177HELENA SYSTEMMAX2011-04-21
1297941614354780K110046ATHENA PEDICLE SCREW SYSTEMNKB2011-12-07
1297941065821232
1297941544026864
1297941571361450
1297941590765881

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB12011-12-07
MAX12011-04-21

GUDID#