Data / Medical devices / United States / Romd, LLC
Romd, LLC: FDA-registered device maker in Rochester Hills, MI, United States, 2 510(k) clearances
Romd, LLC is registered with the FDA (registration 3008959459) in Rochester Hills, MI, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 7, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008959459
- Address
- 2967 Waterview Drive, Rochester Hills, MI, United States, 48309
- Owner or operator
- Royal Oak Medical Devices (10036878)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 3, 2011
- Registered through
- 2026
- Brand names listed
- Agoge Pedicle Screw System, Athena Pedicle Screw System, Helena IBFD System, Hippeis IBFD System, Opus Medical Capella Pedicle Screw System, Opus Medical Gemini IBFD System, Royal Oak IBFD System, Royal Oak Pedicle Screw System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2011 | K110046 | ATHENA PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Royal Oak Medical Devices | accessdata.fda.gov |
| April 21, 2011 | K110177 | HELENA SYSTEM | MAX | Substantially Equivalent | Royal Oak Medical Devices | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated December 7, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.