FDA Registration
Active
🇺🇸 United States
ACUMED LLC
Reg #: 3025141
·
FEI: 1000125930
·
Expires 2026
Products
31
Proprietary Names
76
Establishment Types
3
Classifications
31
Registration Details
- Registration Name
- ACUMED LLC
- Registration Number
- 3025141
- FEI Number
- 1000125930
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5885 NE Cornelius Pass Rd
- City
- Hillsboro
- State
- OR
- ZIP
- 97124
- Country
- US
Regulatory Submissions
- 510(k) Number
- K951673
Owner / Operator
- Firm Name
- ACUMED LLC
- Operator Number
- 9001805
- Address
- 5885 NE CORNELIUS PASS RD., --
- City
- Hillsboro
- State
- OR
- Postal Code
- 97124
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-05-09 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2007-10-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2007-10-24 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2026-04-02 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-04-28 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-11-25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2007-10-24 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-04-02 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2026-04-02 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-11-23 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2023-09-01 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2007-10-24 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-09-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2020-11-24 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2007-10-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-05-05 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2010-10-28 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2010-10-28 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2023-09-01 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2007-10-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-11-22 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-10-29 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2009-06-25 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2026-04-02 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-03-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-03-08 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2007-10-24 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2023-09-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2020-02-20 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-11-07 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2004-03-08 |
Proprietary Names
Acumed Bone Plate System
Cutting Tool, Bit, Drill
Acu-Loc NEXT Wrist Fixation System. Acu-Loc(r) NEXT(TM)
Acumed Suture Anchor
Small Bone IM System
Acumed Congruent Bone Plate System
Stableloc Extrenal Fixator
Acutrak Plus Fixation System
Ankle Plating System 3
Acumed Locking Variable Angle Screws
Acutrak Headless Compression Screw
Acumed Extermity Screw System
Acumed Polarus Modular Shoulder
Acumed Instruments
Acu-Sinch Knotless
Acumed Radius Rod
Acumed Tension Band Pin
Acumed Clavicle Hook Plating System
BioBridge Resorbable Chest Wall Stabilization Plate
Acumed Pelvic Plating System
Acumed Pelvic Bone Plate System
AcuTie II Sternal Closure System
AcuTie Sternal Closure System
Biotrak Screw System
ARC SURGICAL RESORBABLE
Osteo-Clage SS Bone Plate
Acu-Sinch Knotless - Mini
Acu Loc 2 System
Acumed Wrist Plating System
Acu Loc System
Acumed Bone Graft System
Bone Graft Harvesting System
RibLock Low Profile Guide
Acumed ARH Slide-Loc System
Acumed Anatomic Radial Head System
ARH Slide-Loc Radial Head Solutions
Slide-Loc Anatomic Radial Head System
Acumed Anatomic Radial Head Solutions 2
Acumed Anatomic Radial Head Solutions
ARH Solutions 2
ARH Solutions
Acumed Lower Extremity Plating System
Lower Extremity Congruent Bone Plat
Small Fragment Base Set
Acumed Clavicle Screw System
RibLoc U plus Fracture Plating System
RibLoc U Plus 90 Instrumentation
RibLoc Rib Fracture Plating System
Acumed Hand Fracture System
Acumed Hand Plating System
Acumed External Fixator
Acumed 3.5mm Extremity Screw
Cannulated Cancellous Bone Screw
Acumed Cannulated Screw System
Screw Caddy
Tray Lid
Tray Base
Instrument Tray
Tray Assembly
Implant Tray
Acumed Orthopaedic Wires
Acumed Wrist Arthrodesis/Fusion Plate System
SLIC Bone Reduction Screw
Cortical Bone Screw
Acumed Templates
Congruent Bone Plate System
Acumed Small Bone External Fixator
SLIC Screw Repair System
Acumed Cerclage Crimp Sleeve
AcuTie Sternal System
Acumed Scapula Congruent Bone Plate
Acumed Acutrak System, Acumed Acturak 2 System
Acumed Small Bone Locking Rod II
Acumed Small Bone Locking Rods
Acu-Sinch Repair System
Acumed HubCap Wrist Fusion Plate
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device