Data / Medical devices / United States / Advanced Research Medical
Advanced Research Medical: FDA-registered device maker in Burnsville, MN, United States, 2 510(k) clearances
Advanced Research Medical is registered with the FDA (registration 3016002322) in Burnsville, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016002322
- Address
- 1515 Highway 13 East, Burnsville, MN, United States, 55337
- Owner or operator
- ADVANCED RESEARCH MEDICAL, LLC (10061561)
- Roles
- Manufacturer
- First device listed
- October 29, 2019
- Registered through
- 2026
- Brand names listed
- Arrow, Interbody Preparation Instruments, Posterior Fixation Instruments, Trident
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 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 |
|---|---|---|---|---|---|---|
| January 22, 2021 | K203373 | Advanced Research Medical Trident SI Screw System | OUR | Substantially Equivalent | Advanced Research Medical, LLC | accessdata.fda.gov |
| July 25, 2018 | K173947 | Lumbar Interbody Fusion System (OLLIF) | MAX | Substantially Equivalent | Advanced Research Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 14, 2023 | 94279 | Class II | Completed | ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease | Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Sacroiliac Joint Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated April 29, 2024. 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.