Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012470322

FEI Number

3012470322

Entity Name

Arthrex Japan G.K. (Shinjuku)

City/State/Country

Shinjuku-ku Tokyo, JP

Establishment Address

Shinjuku NS BLDG 28F, 2-4-1 Nishi-Shinjuku, Shinjuku-ku Tokyo 1630828, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ARTHREX, INC. (Owner Number: 1220287)

Owner / Operator Contact Address

1370 CREEKSIDE BLVD., --, Naples, FL 34108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMPRESSION STAPLE Instrument, manual, surgical, general use fixation plate LOW PROFILE PLATE AND SCREW SYSTEM orthopedic manual instrument Arthrex Distal Extremity Plate System Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Arthrex Fracture System ORTHOPEDIC MANUAL INSTRUMENTS Laproscopes fixation plate SHAVER BLADES orthopedic manual instrument SHOULDER HOLDER Apparatus, Traction, Non-Powered Syringe, piston Insufflator 50L FM134 single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes PARS Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-02
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-06-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-02-10
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2018-02-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-05-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-05-17
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-08-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-12-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-05-22
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-05-22
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-07-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-11-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-26
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2021-09-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-03-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-03-09
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-03-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-02-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2012-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-16
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-04-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-04-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-11
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2007-08-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-08-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-12-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-12-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-29
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-08-29
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-01-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-08-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-04-24
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-04-24
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2021-09-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2021-09-13
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-03-21
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-10-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-12-01
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1994-01-27

Official Correspondent

Barry Dietz

US Agent Details

Barry Dietz Business: ARTHREX, INC. Email: Regulatory_Affairs@arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

ARTHREX, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031238646	Arthrex Medical Device (Shanghai) Co. Ltd.	Shanghai, CN
3007193505	ARTHREX GMBH	Odelzhausen Bavaria, DE
3013700547	Arthrex Korea Ltd.	Gangnam-gu Seoul, KR
3014004349	Arthrex Singapore Pte Ltd.	Singapore Central Singapore, SG
3020704423	Arthrex New Zealand Limited	Auckland, NZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
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 3012470322. Last updated year: 2026. Please use registration number 3012470322 when referencing this establishment in official correspondence.