ROMD, LLC

FDA Device Registration & Listing · Rochester Hills, MI, US · Registration 3008959459

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008959459
FEI Number
3008959459
Entity Name
ROMD, LLC
City/State/Country
Rochester Hills, MI, US
Establishment Address
2967 Waterview Drive, Rochester Hills, MI 48309, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Royal Oak Medical Devices (Owner Number: 10036878)
Owner / Operator Contact Address
2967 Waterview Drive, Rochester Hills, MI 48309, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Helena IBFD System Hippeis IBFD System Opus Medical Gemini IBFD System Royal Oak IBFD System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-10-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-06-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-12-23

Official Correspondent

David Zagorowski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Royal Oak Medical Devices
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008959459. Last updated year: 2026. Please use registration number 3008959459 when referencing this establishment in official correspondence.
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