Medical Device Manufacturer · US , Hillsboro , OR

Acumed, LLC

38 submissions · 38 cleared · Since 2003
38
Total
38
Cleared
0
Denied

Acumed, LLC — FDA 510(k) Submissions

Acumed, LLC has submitted 38 FDA 510(k) premarket notifications since 2003, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Washer, Bolt Nut, Rod, Fixation, Intramedullary And Accessories, Prosthesis, Elbow, Hemi-, Radial, Polymer . Use the specialty filter in the sidebar to narrow results.

38 devices
1–12 of 38
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2025 23d
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
K251132 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2025 94d
The Acumed Wrist Fixation System
K251296 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2025 54d
Acu-Sinch Knotless Mini
K243624 · HTN Washer, Bolt Nut · Orthopedic
Jan 2025 59d
Acumed Wrist Plating System
K233311 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2024 206d
Acumed Acutrak 3 Headless Compression Screw System
K230744 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2023 84d
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K221333 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2022 234d
Acumed Ankle Syndesmosis Repair System
K212990 · HTN Washer, Bolt Nut · Orthopedic
Jan 2022 109d
Acumed Clavicle Hook Plating System
K210750 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2021 125d
Acumed Ankle and Small Fragment Base Set Update
K151886 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2015 113d
Acumed Ankle Plating System
K143385 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2015 131d
Acumed Small Bone IM Nail System
K143276 · HSB Rod, Fixation,... · Orthopedic
Feb 2015 83d

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