What does Arthrex (Shanghai) Co., Ltd. manufacture?

Registered with the FDA for 38 device types.

Is Arthrex (Shanghai) Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Arthrex (Shanghai) Co., Ltd. → Supplier → Allomedo

Arthrex (Shanghai) Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Reamer, Template and 36 other device types. Its earliest product listing with the FDA dates from 1994.

Registration

FDA registration record for Arthrex (Shanghai) Co., Ltd.
Status	Registered
Registration expires	2026
Registration number	3014262693
FEI number	3014262693
Establishment type	Exporter

Location

Address of Arthrex (Shanghai) Co., Ltd.
City	Shanghai
Province	Shanghai
Address	2205-2208 Garden Square
Postal code	200041
Country	China

Group

Arthrex (Shanghai) Co., Ltd. is one of 2 plants registered under ARTHREX, INC..

Other plants under ARTHREX, INC.
Plant	City	Device types
Arthrex Medical Device (Shanghai) Co., Ltd.	Shanghai	3

What It Makes

Device types Arthrex (Shanghai) Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessories, Arthroscopic	Class 1	Various Instruments	2007	14
Apparatus, Traction, Non-Powered	Class 1	Shoulder Holder, Apparatus, Traction, Non-Powered	2007	44
Arthroscope	Class 2	Dual Wave Pump, Continuous Wave III, Arthroscopes	2008	21
Bit, Drill	Class 1	drill bit	2007	27
Blade, Saw, General & Plastic Surgery, Surgical	Class 1	Shaver Blades	2007	25
Camera, Television, Surgical, Without Audio	Class 1	Camera, Television, Surgical, Without Audio	2024	5
Cerclage, Fixation	Class 2		2022	5
Electrosurgical, Cutting & Coagulation & Accessories	Class 2		2007	65
Fastener, Fixation, Biodegradable, Soft Tissue	Class 2	Corkscrew Anchors, Arthrex Biocomposite Transfix, Arthrex BioComposite SutureTak, Pushlock, Arthrex Pushlock, Tenodesis Family and 9 more	2007	2
Fastener, Fixation, Nondegradable, Soft Tissue	Class 2	Corkscrew Anchors, Arthrex Tibial GraftBolt, Pushlock, smooth or threaded metallic bone fixation fastener, Tenodesis Family, TAK Family and 6 more	2007	7
Gauge, Depth	Class 1	orthopedic manual instrument	2001	14
Guide, Drill, Ligament	Class 1		2018	3
Instrument, Manual, Surgical, General Use	Class 1	Instrument, manual, surgical, general use	2007	110
Instrument, Special Lens, For Endoscope	Class 1	Instrument, Special Lens, For Endoscope	2017	1
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class 1	Shaver System, Instrument, Surgical, Orthopedic, AC-Powered Motor AND Accessory/Attachment	1996	23
Laparoscope, General & Plastic Surgery	Class 2	Laproscopes	2012	46
Orthopedic Manual Surgical Instrument	Class 1	Orthopedic Manual Instruments	2007	53
Pin, Fixation, Smooth	Class 2	ACL TightRope Double Bundle, ACL TightRope, fixation pin, Arthrex PCL TightRope	2007	12
Plate, Fixation, Bone	Class 2	Arthrex Low Profile Screws, Arthrex Ankle Fusion Plating System, Single/multiple component metallic bone fixation appliances and accessories, fixation plate, LOW Profile Plate AND Screw System, Arthrex Distal Extremity Plate System and 5 more	2008	22
Platelet And Plasma Separator For Bone Graft Handling	Class 2		2020	2
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class 2	Univers II	2008	8
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class 2	Univers II, Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi	2008	9
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class 2		2019	2
Punch, Surgical	Class 1	orthopedic manual instrument	2003	9
Reamer	Class 1	orthopedic manual instrument	1994	23
Screw, Fixation, Bone	Class 2	Corkscrew Anchors, Arthrex Biocomposite Transfix, Arthrex BioComposite SutureTak, Arthrex Low Profile Screws, Pushlock, Arthrex Ankle Fusion Plating System and 19 more	2007	31
Shoulder Arthroplasty Implantation System	Class 2		2023	1
Shoulder Prosthesis, Reverse Configuration	Class 2	Shoulder joint metal/ polymer semi-constrained cemented prosthesis, Univers Revers Shoulder Prosthesis System, Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi	2015	9
Staple Driver	Class 1	orthopedic manual instrument	2008	1
Staple, Fixation, Bone	Class 2	Corkscrew Anchors, Compression Staple, orthopedic manual instrument, Arthrex Plates, Screws, and Staples	2007	7
Suture, Nonabsorbable, Silk	Class 2	ACL TightRope Double Bundle, Retrobutton	2008	4
Suture, Nonabsorbable, Synthetic, Polyethylene	Class 2	ACL TightRope Double Bundle, Arthrex Suture, Fiberstick, FiberWire, FiberTape, Retrobutton and 3 more	2007	6
Syringe, Piston	Class 2	Double Syringe (ACP) System	2009	60
System, Image Processing, Radiological	Class 2	Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi	2018	16
System, X-Ray, Angiographic	Class 2		2024	7
Template	Class 1	Orthopedic Template	2014	21
Total Shoulder Arthroplasty System	Class 2		2019	1
Washer, Bolt Nut	Class 2	Arthrex Ankle Fusion Plating System, Single/multiple component metallic bone fixation appliances and accessories, Mini TightRope CMC, Arthrex Mini TightRopes, Washer	2007	9

Clearances

No clearance names Arthrex (Shanghai) Co., Ltd. as applicant. 100 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Arthrex (Shanghai) Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K243008	2025-01-22	GCJ	Traditional	Arthrex, Inc.
K241361	2024-07-25	GCJ	Traditional	Arthrex, Inc.
K241235	2024-05-29	MBI	Special	Arthrex, Inc.
K233451	2024-01-18	GCJ	Traditional	Arthrex, Inc.
K232973	2023-11-15	MBI	Traditional	Arthrex, Inc.
K232755	2023-10-06	HTN	Special	Arthrex, Inc.
K231330	2023-06-01	MBI	Special	Arthrex, Inc.
K231113	2023-05-18	MBI	Special	Arthrex, Inc.
K230568	2023-04-01	MBI	Special	Arthrex, Inc.
K222007	2023-03-08	QHE	Traditional	Arthrex, Inc.
K221396	2022-12-22	MBI	Traditional	Arthrex, Inc.
K221731	2022-09-07	MBI	Traditional	T.A.G. Medical Products Corporation Ltd
K221485	2022-08-22	HTN	Traditional	Arthrex, Inc.
K222161	2022-08-11	MBI	Special	Arthrex, Inc.
K221099	2022-05-13	MAI	Special	Arthrex, Inc.
K203495	2021-04-19	MAI	Traditional	Arthrex, Inc.
K203294	2021-02-03	HRS	Traditional	Arthrex, Inc.
K203268	2020-11-27	MBI	Special	Arthrex, Inc.
K202535	2020-11-18	MAI	Special	Arthrex, Inc.
K202581	2020-11-04	MBI	Traditional	Arthrex, Inc.
K201132	2020-07-27	HRS	Traditional	Arthrex, Inc.
K201542	2020-07-08	PKC	Special	Arthrex, Inc.
K200341	2020-03-12	MBI	Special	Arthrex, Inc.
K193157	2019-12-12	MAI	Special	Arthrex, Inc.
K183194	2019-07-26	QHQ	Traditional	Arthrex, Inc.
K191226	2019-06-11	MAI	Special	Arthrex, Inc.
K181769	2018-09-21	MBI	Traditional	Arthrex, Inc.
K180594	2018-06-22	MAI	Traditional	Arthrex, Inc.
K180662	2018-05-22	MAI	Special	Arthrex, Inc.
K173900	2018-04-20	PHX	Traditional	Arthrex, Inc.
K180118	2018-02-12	MBI	Special	Arthrex, Inc.
K172612	2017-09-28	MBI	Special	Arthex, Inc.
K170547	2017-09-01	HRS	Traditional	Arthrex, Inc.
K162697	2017-02-10	KWS	Traditional	Custom Orthopaedic Solutions, Inc.
K161782	2016-11-21	HSD	Traditional	Arthrex, Inc.
K161581	2016-09-09	GEI	Traditional	Arthrex, Inc.
K161108	2016-08-29	KWS	Special	Arthrex, Inc.
K151527	2016-04-19	HSD	Traditional	Arthrex, Inc.
K151342	2016-03-24	MAI	Traditional	Arthrex, Inc.
K151092	2016-02-23	MBI	Traditional	Arthrex, Inc.
K153218	2016-02-12	GCJ	Traditional	Arthrex, Inc.
K143745	2015-07-02	MBI	Traditional	Arthrex, Inc.
K151230	2015-06-19	MBI	Special	Arthrex, Inc.
K150456	2015-04-29	HRS	Special	Arthrex, Inc.
K143614	2015-01-16	HWC	Special	Arthrex, Inc.
K140855	2014-12-18	MAI	Traditional	Arthrex, Inc.
K142863	2014-11-25	PHX	Traditional	Arthrex, Inc.
K141735	2014-08-15	HRS	Special	Arthrex, Inc.
K141478	2014-07-08	HRS	Special	Arthrex, Inc.
K133275	2014-01-30	HTN	Traditional	Arthrex, Inc.
K132217	2013-11-25	HWC	Traditional	Arthrex, Inc.
K132043	2013-07-31	GAT	Special	Arthrex, Inc.
K131474	2013-07-03	HRS	Traditional	Arthrex, Inc.
K130458	2013-05-03	MBI	Traditional	Arthrex, Inc.
K123241	2013-04-05	HRS	Traditional	Arthrex, Inc.
K123341	2012-12-21	MBI	Traditional	Arthrex, Inc.
K122374	2012-09-25	GAT	Special	Arthrex, Inc.
K121124	2012-05-16	FMF	Traditional	Arthrex, Inc.
K112990	2011-12-19	HTY	Traditional	Arthrex, Inc.
K112040	2011-12-15	MAI	Special	Arthrex, Inc.
K112237	2011-09-02	HWC	Special	Arthrex, Inc.
K111253	2011-08-02	HRS	Traditional	Arthrex, Inc.
K110123	2011-04-28	HTY	Traditional	Arthrex, Inc.
K110660	2011-03-31	MAI	Special	Arthrex, Inc.
K103705	2011-03-18	HWC	Traditional	Arthrex, Inc.
K101823	2011-01-07	MAI	Traditional	Arthrex, Inc.
K103060	2011-01-05	MBI	Special	Arthrex, Inc.
K101837	2010-12-28	HTY	Traditional	Arthrex, Inc.
K101679	2010-10-22	MAI	Traditional	Arthrex, Inc.
K100652	2010-06-23	HTY	Special	Arthrex, Inc.
K093912	2010-03-18	MBI	Traditional	Arthrex, Inc.
K091844	2009-08-28	MAI	Special	Arthrex, Inc.
K090107	2009-08-06	HTN	Traditional	Arthrex, Inc.
K083707	2009-08-03	HRX	Traditional	Arthrex, Inc.
K082810	2009-01-23	MAI	Traditional	Arthrex, Inc.
K080560	2008-03-18	HRX	Traditional	Henke Sass Wolf OF America, Inc.
K080111	2008-02-13	JDR	Traditional	Arthrex, Inc.
K073149	2008-02-11	GAT	Traditional	Arthrex, Inc.
K071032	2007-08-20	KWS	Special	Arthrex, Inc.
K071756	2007-08-15	GCJ	Traditional	Pointe Conception Medical, Inc.
K071176	2007-08-03	MAI	Traditional	Arthrex, Inc.
K063479	2006-12-13	HWC	Special	Arthrex, Inc.
K062466	2006-11-29	MAI	Traditional	Arthrex, Inc.
K061863	2006-10-19	HWC	Traditional	Arthrex, Inc.
K062747	2006-09-29	HRS	Special	Arthrex, Inc.
K053510	2006-03-20	GEI	Traditional	Linemaster Switch Corp.
K053338	2006-01-26	HWC	Traditional	Arthrex, Inc.
K052776	2005-12-13	HTN	Traditional	Arthrex, Inc.
K052736	2005-11-03	HTY	Traditional	Arthrex, Inc.
K052614	2005-09-28	HRS	Special	Arthrex, Inc.
K051726	2005-09-27	HWC	Traditional	Arthrex, Inc.
K050749	2005-05-12	HWC	Traditional	Arthrex, Inc.
K043248	2005-02-16	HTN	Traditional	Arthrex, Inc.
K041553	2004-12-10	GAT	Traditional	Arthrex, Inc.
K032187	2003-09-22	HRS	Traditional	Arthrex, Inc.
K024291	2003-03-20	HRX	Traditional	Arthrex, Inc.
K021434	2002-11-07	GAT	Traditional	Arthrex, Inc.
K943492	1995-02-01	JDR	Traditional	Arthrex, Inc.
K941541	1994-05-16	GCJ	Traditional	Henke Sass Wolf OF America, Inc.
K932699	1994-01-25	HWE	Traditional	Arthrex, Inc.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Arthrex (Shanghai) Co., Ltd.
Founded	1981
Main products	minimally invasive orthopedic instruments, surgical devices, medical education products
Export markets	global/worldwide

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Shanghai Yuechen Medical Supply Co..ltd.	1
Shanghai Bolan Optical Electric Co., Ltd.	1
Biomobie (Shanghai) Regenerative Medicine Co., Ltd.	1
Shanghai Waylong Intelligent Technology Co., Ltd.	1
Wisdom Medical Technology (Shanghai) Co., Ltd.	1
Pigeon Manufacturing (Shanghai) Co., Ltd.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Arthrex (Shanghai) Co., Ltd.