Arthrex Chile SPA

FDA Device Registration & Listing · Pudahuel Region Metropolitana, CL · Registration 3027339877

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027339877
FEI Number
3027339877
Entity Name
Arthrex Chile SPA
City/State/Country
Pudahuel Region Metropolitana, CL
Establishment Address
Camino a Noviciado, number: 3707, modulo 13-14, Pudahuel Region Metropolitana 9020000, CL
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
N
Expiration Date (Year)
2026
510(k) Number
K112990
PMA Number
N/A

All Registered Proprietary Names

Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories orthopedic manual instrument Arthrex Fracture System orthopedic manual instrument Arthrex Plates, Screws, and Staples Arthrex Distal Extremity Plate System Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System MINI TIGHTROPE ARTHROERESIS IMPLANT orthopedic manual instrument orthopedic manual instrument orthopedic manual instrument Arthrex Low Profile Screws INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT VARIOUS INSTRUMENTS Orthopedic Template Component, Traction, Non-Invasive BIOCOMPOSITE SUTURE ANCHORS ARTHROSCOPY LEG HOLDER Arthrex MicroSuture Anchors SHAVER SYSTEM smooth or threaded metallic bone fixation fastener Arthrex Tibial GraftBolt Bio-Composite SutureTak Fracture Plates & Screws Arthrex SwiveLock Anchors Arthrex PCL TightRope General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Camera Heads BIO-PIN Arthrex Fracture System fixation plate LOW PROFILE PLATE AND SCREW SYSTEM drill bit Metallic Bone Fixation Biosync Bone wedge Biosync SHOULDER HOLDER Apparatus, Traction, Non-Powered MALLET, SURGICAL, GENERAL & PLASTIC SURGERY COMPRESSION STAPLE DOUBLE SYRINGE (ACP) SYSTEM WASHER Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Graft Delivery Device with Integrated Stylet OSTEOTOMY PLATE WASHER ORTHOPEDIC MANUAL INSTRUMENTS CONTINUOUS WAVE III TENODESIS FAMILY INTERFERENCE SCREWS Instrument, manual, surgical, general use Arthrex Suture Arthrex Fracture Plates Arthrex Minimally Invasive Ankle Fusion Plate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-09-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
HTO Reamer Orthopedic Class 1 888.4540 1994-01-27
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
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-08-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-08-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-08-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-12-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-03-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2017-05-30
HXB Probe Orthopedic Class 1 888.4540 2003-08-07
HXJ Staple Driver Orthopedic Class 1 888.4540 2008-11-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2018-07-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-07-27
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2007-08-23
HWT Template Orthopedic Class 1 888.4800 2014-08-21
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 1996-08-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-04-16
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-24
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-04-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-11-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-11-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-05-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-05-22
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-09-14
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-09-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-09-14
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-02
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2010-04-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-09-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-09-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2015-01-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-05-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-05-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-06-14
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-12-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-12-20
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2021-08-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-08
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2017-01-25
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2017-01-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-31
PLF Bone Wedge Orthopedic Class 2 888.3030 2015-12-31
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2021-09-13
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2009-04-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-02-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-09-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-09-08
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-10-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-04-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-04-11
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2021-09-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-17
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
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-04-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-05-15
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-05-15

Official Correspondent

No official correspondent registered.

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
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
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

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 3027339877. Last updated year: 2026. Please use registration number 3027339877 when referencing this establishment in official correspondence.
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