Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020704423

FEI Number

3020704423

Entity Name

Arthrex New Zealand Limited

City/State/Country

Auckland, NZ

Establishment Address

6 Fox Street, Auckland 1052, NZ

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

K162697

PMA Number

N/A

All Registered Proprietary Names

Arthrex Minimally Invasive Ankle Fusion Plate Arthrex Low Profile Screws RETROBUTTON Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Camera Heads MINI TIGHTROPE BI-CORTICAL BIO-POST AND WASHER Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture Fracture Plates & Screws Arthrex SwiveLock Anchors Arthrex Pushlock Insufflator 50L FM134 Arthrex Distal Extremity Plate System Arthrex PCL TightRope ACL TightRope UNIVERS SHOULDER Component, Traction, Non-Invasive orthopedic manual instrument Fastener, Fixation, nondegradable, soft tissue fixation plate single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Low Profile Screws Arthrex Fracture Plates CORKSCREW ANCHORS SHAVER SYSTEM BIO-PIN WASHER FINGERSHIELD orthopedic manual instrument UNIVERS II CONTINUOUS WAVE III MENISCAL DART, DARTSTICK, CHONDRAL DART COMPRESSION STAPLE BIO-COMPRESSION SCREW Metallic Bone Fixation Biosync Bone wedge Biosync ARTHROERESIS IMPLANT Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories VARIOUS BURS orthopedic manual instrument display, cathode-ray tube, medical Pliers, Surgical Source, Carrier, Fiberoptic Light Arthrex Knotless SutureTak Anchor Graft Delivery Device with Integrated Stylet Dual Wave Pump Orthopedic manual surgical instrument, Passer Balance, Analytical PUSHLOCK Arthrex MicroSuture Anchors DOUBLE SYRINGE (ACP) SYSTEM Arthrex Plates, Screws, and Staples General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure FASTAK SUTURE ANCHOR BIOCOMPOSITE SUTURE ANCHORS Table Attachments, Operating-Room TENODESIS FAMILY Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-11
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-19
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
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-02-10
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-03-08
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-02-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-10
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
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-12-23
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2024-04-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-11-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-09-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-09-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-12-21
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-01-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-03
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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-11-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-11-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-11-06
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-06-06
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-07-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-07-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2008-11-26
HTN	Washer, Bolt Nut	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	2014-02-26
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
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
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-07-09
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-07-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-23
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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-01-31
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-31
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	2023-03-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-05-29
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
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
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
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1996-08-07
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-03-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-03-21
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-08-20
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-06-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-06-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-05
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	2014-03-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-01-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-01-16
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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-16
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
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
LZB	Finger Cot	General Hospital	Class 1	880.6250	2005-12-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-08-20
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-08-13
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
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
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
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-12-01
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-12-01
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	2022-09-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-07-31
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-09-26
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
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-12-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-31
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-04-09
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-12-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-05
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-12-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-04-14
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-06-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-01-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-06-15
HTO	Reamer	Orthopedic	Class 1	888.4540	1994-01-27
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2023-05-22
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-08-29
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2024-08-29
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-10-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-10-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-06-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-12-01
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
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-17
HWQ	Passer	Orthopedic	Class 1	888.4540	2003-08-07
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2023-08-03
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-07
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
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-08-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-16
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-28
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-07-03
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-12-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-12-18
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
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-09-01
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-24
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-05-18
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-05-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-05-18

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
3011230048	Arthrex Mexico, S.A. de C.V.	Col. Napoles Mexico, MX

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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
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number	Establishment Name	Location
1219930	Covidien	North Haven, CT, US
3016660811	SUBCHONDRAL SOLUTIONS	Costa Mesa, CA, US
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020704423. Last updated year: 2026. Please use registration number 3020704423 when referencing this establishment in official correspondence.