Data / Medical devices / United States / Acumed LLC -Brookwood Facility
Acumed LLC -Brookwood Facility: FDA-registered device maker in Hillsboro, OR, United States, 3 510(k) clearances
Acumed LLC -Brookwood Facility is registered with the FDA (registration 3008396464) in Hillsboro, OR, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 14, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008396464
- Address
- 4860 NE Brookwood Parkway, Hillsboro, OR, United States, 97124
- Owner or operator
- ACUMED LLC (9001805)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 28, 2020
- Registered through
- 2027
- Brand names listed
- Acu-Loc NEXT Wrist Fixation System. Acu-Loc(r) NEXT(TM), Acu-Sinch Knotless - Mini, Cutting Tool, Bit, Drill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 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 |
|---|---|---|---|---|---|---|
| July 14, 2025 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 18, 2025 | K251296 | The Acumed Wrist Fixation System | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 23, 2025 | K243624 | Acu-Sinch Knotless Mini | HTN | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Washer, Bolt Nut
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
Updated July 14, 2025. 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.