FDA.reportPublic FDA data

Acumed LLC -Brookwood Facility

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083964643008396464Acumed LLC -Brookwood Facility1N2026-01-014860 NE Brookwood Parkway Hillsboro OR US 97124

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2088701906951234K251296The Acumed Wrist Fixation SystemHRS2025-06-18
2088701003703125K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS2025-07-14
2088701916662917K243624Acu-Sinch Knotless MiniHTN2025-01-23
2088701624923557

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS22025-07-14
HTN12025-01-23