Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019269298

FEI Number

3019269298

Entity Name

Arthrex Australia Pty Ltd.

City/State/Country

Frenchs Forest New South Wales, AU

Establishment Address

Suite 501, 20 Rodborough Road, Frenchs Forest New South Wales 2086, AU

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

K014155

PMA Number

N/A

All Registered Proprietary Names

Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Arthrex Distal Extremity Plate System Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Arthrex Suture Dual Wave Pump Arthrex Minimally Invasive Ankle Fusion Plate BIO-CORKSCREW FT UNIVERS II fixation plate Arthroscope Arthrex Fracture System UNIVERS SHOULDER Arthroscopes BIO-ABSORBABLE CORKSCREW General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure BI-CORTICAL BIO-POST AND WASHER BIO-FASTAK SUTURE ANCHOR CORKSCREW ANCHORS Arthrex PushLock Tenodesis Anchor orthopedic manual instrument VARIOUS BURS Mini TightRope CMC Laproscopes TAK FAMILY ACL TightRope Balance, Analytical Arthrex Tibial GraftBolt display, cathode-ray tube, medical BIO-PIN Arthrex Fracture Plates Source, Carrier, Fiberoptic Light orthopedic manual instrument UNIVERS FRACTURE orthopedic manual instrument Bio-Composite SutureTak BIO-COMPRESSION SCREW BIOCOMPOSITE INTERFERENCE SCREW Arthrex Fracture System SHAVER BLADES Insufflator 50L FM134 fixation pin Orthopedic manual surgical instrument, Passer Arthrex BioComposite SutureTak Arthrex Tibial GraftBolt DOUBLE SYRINGE (ACP) SYSTEM Arthrex Plates, Screws, and Staples fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Arthrex MicroSuture Anchors ORTHOPEDIC MANUAL INSTRUMENTS orthopedic manual instrument FiberTape Fiberstick FiberWire Table Attachments, Operating-Room Arthrex SwiveLock Anchors SHAVER SYSTEM Arthrex Graft-Anchor drill bit ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P MENISCAL CINCH Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System VARIOUS IMPLANTS BIOCOMPOSITE SUTURE ANCHORS Camera Heads MENISCAL DART, DARTSTICK, CHONDRAL DART Instrument, manual, surgical, general use Orthopedic Template ACL TightRope Double Bundle INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT VARIOUS INSTRUMENTS ARTHROERESIS IMPLANT COMPRESSION STAPLE PARS Needle iBalance DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER HUMERAL FRACTURE PLATE Fracture Plates & Screws Arthrex Univers II Glenoid Components TENODESIS FAMILY Univers II SHOULDER HOLDER Apparatus, Traction, Non-Powered Graft Delivery Device with Integrated Stylet Component, Traction, Non-Invasive Camera, Television, Surgical, Without Audio smooth or threaded metallic bone fixation fastener orthopedic manual instrument OSTEOTOMY SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-03-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-04-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-11-15
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2017-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-25
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-11
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-09-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-11-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-11-26
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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-04-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-11-26
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
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-11-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-11-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-11-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-08-30
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2007-08-23
JDR	Staple, Fixation, Bone	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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-06
HXB	Probe	Orthopedic	Class 1	888.4540	2003-08-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-11-17
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2007-08-23
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-09-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-09-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-06-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-12-07
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2009-12-07
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2007-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2010-06-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2010-06-23
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2023-08-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2013-06-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-06-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2010-04-13
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
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2023-05-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2024-08-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-11-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-08
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-20
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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-19
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-24
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
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-04-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-06-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-10
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2016-02-25
HWQ	Passer	Orthopedic	Class 1	888.4540	2003-08-07
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	2011-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-04-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-05-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-02-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
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
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	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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-09-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-09-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
HTO	Reamer	Orthopedic	Class 1	888.4540	1994-01-27
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-28
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-07-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2016-06-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-06-14
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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-31
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2021-09-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-08-23
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2007-01-31
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
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	2022-08-23
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2022-08-23
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-09-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-09-05
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-01-25
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2009-04-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2009-04-16
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-07-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-04-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-05
HWT	Template	Orthopedic	Class 1	888.4800	2014-08-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-03-13
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2011-01-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2011-01-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-01-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-05-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-05-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1996-08-07
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-21
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-05-03
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-09-03
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-06-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1994-01-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-08-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-12-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-03-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-03-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
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
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-05-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-05-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2014-08-25
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-09-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2009-09-08
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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-06-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-08-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-08-06
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1996-08-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2019-07-26
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2019-07-26
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-07-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-01-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-06-23
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-09-26
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2001-07-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26

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
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28
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

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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3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
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3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019269298. Last updated year: 2026. Please use registration number 3019269298 when referencing this establishment in official correspondence.