Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032588003

FEI Number

3032588003

Entity Name

HG MEDICAL USA, LLC

City/State/Country

Holland, MI, US

Establishment Address

701 S Waverly Rd, Holland, MI 49423, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HG Medical USA, LLC (Owner Number: 10078829)

Owner / Operator Contact Address

810 Memorial Blvd., Huntington, WV 25701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Ankle Fusion Plates and Screws TMC 3 1.25 pitch Locking Screw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-02-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-05-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-08-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-02-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-02-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HG Medical USA, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

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.

Similar Registrations

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3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032588003. Last updated year: 2026. Please use registration number 3032588003 when referencing this establishment in official correspondence.