Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025141

FEI Number

1000125930

Entity Name

ACUMED LLC

City/State/Country

Hillsboro, OR, US

Establishment Address

5885 NE Cornelius Pass Rd, Hillsboro, OR 97124, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

ACUMED LLC (Owner Number: 9001805)

Owner / Operator Contact Address

5885 NE CORNELIUS PASS RD., --, Hillsboro, OR 97124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Ankle Plating System 3 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 Bone Plate System 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-05-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
JEY	Plate, Bone	Dental	Class 2	872.4760	2026-04-02
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-25
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-11-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2007-10-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-02-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2026-04-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-09-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-03-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-11-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2023-09-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-24
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-09-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-06-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-06-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-08-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-08-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2020-11-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-06-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2007-10-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-05-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2013-08-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-09-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-01-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-01-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-01-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2007-10-24
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-03-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-27
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2010-10-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2010-10-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-10-28
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2007-10-24
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2023-09-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-11-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2005-06-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-01
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-05-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-15
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2007-10-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-06-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-11-23
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-10-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-02-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-02-27
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2009-06-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-10-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-10-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-06-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-06-24
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2007-10-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-24
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2026-04-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2026-04-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-24
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2013-03-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-03-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-01
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2007-10-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-11-09
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2023-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACUMED LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008396464	Acumed LLC -Brookwood Facility	Hillsboro, OR, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025141. Last updated year: 2026. Please use registration number 3025141 when referencing this establishment in official correspondence.