MedtechSourcebook

ROMD, LLC

Contract manufacturer ยท Rochester Hills, MI

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2012Product codes first listed, by year (tallest: 1)2026
FDA registration
3008959459 (openFDA record; or search FDA's registration database)
FEI number
3008959459
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Royal Oak Medical Devices (FDA owner/operator no. 10036878)
Registered address
2967 Waterview Drive, Rochester Hills, MI 48309
Contract listings
4 device listings, 2 product codes, first listed Oct 26, 2012
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingOct 26, 2012
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingDec 23, 2015