Data / Medical devices / United States / Arthrex Logistic Center

Arthrex Logistic Center: FDA-registered device maker in Fort Myers, FL, United States, 31 510(k) clearances

Name: Arthrex Logistic Center FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arthrex Logistic Center is registered with the FDA (registration 3009423112) in Fort Myers, FL, United States. It lists 31 device types. The FDA files 31 510(k) clearances under its listings, the newest dated May 11, 2017. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009423112
Address: 14550 Plantation Road, Fort Myers, FL, United States, 33912
Owner or operator: ARTHREX, INC. (1220287)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: January 27, 1994
Registered through: 2027
Brand names listed: ACL TightRope, ANATOEMIC PROSTHESIS, ARTHREX ANATOEMIC P, Arthrex Distal Extremity Plate System, Arthrex Low Profile Screws, Arthrex PCL TightRope, Arthrex Suture, Arthrex Univers II Glenoid Components and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Balance, Analytical	JQO	1	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Manufacturer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Manufacturer	accessdata.fda.gov
Camera, Cine, Endoscopic, Without Audio	FWL	1	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Manufacturer	accessdata.fda.gov
Prosthesis, Toe, Hemi-, Phalangeal	KWD	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Manufacturer	accessdata.fda.gov
Staple Driver	HXJ	1	Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2017	K170382	Arthrex Compression Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 19, 2016	K151527	Arthrex Univers Revers CA Heads and Adapters	HSD	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 25, 2014	K142863	Univers Rivers Shoulder Prosthesis System	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 25, 2013	K132217	ARTHREX COMPRESSION FT SCREWS	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 3, 2013	K131474	ARTHREX DISTAL RADIUS PLATE SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 21, 2012	K123341	ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 25, 2012	K122374	ARTHREX SUTURE (UHMWPE)	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 16, 2012	K121124	ARTHREX MIXING AND DELIVERY SYSTEM	FMF	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 8, 2012	K120044	ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 19, 2011	K112990	ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 2, 2011	K111253	ARTHREX DISTAL EXTREMITY PLATE SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 28, 2011	K110123	PCL TIGHTROPE	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 18, 2011	K103705	LOW PROFILE SCREWS	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 22, 2010	K103466	ARTHREX UNIVERS II SHOULDER PROSTHESIS	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 23, 2010	K100652	ACL TIGHTROPE	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 6, 2009	K090107	MINI TIGHTROPE	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 11, 2008	K073149	MENISCAL CINCH	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 20, 2007	K071032	ARTHREX UNIVERS II SHOULDER PROSTHESIS	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 3, 2007	K063058	ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS	KWD	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 29, 2006	K062747	ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 29, 2006	K062365	ARTHREX ASPIRATE KIT	FMF	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2005	K052614	LOW PROFILE PLATE AND SCREW SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 16, 2005	K043248	TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 10, 2004	K041553	ARTHREX SUTURE GRAFTING KIT	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 8, 2004	K041965	ARTHREX HUMERAL FRACTURE PLATES AND SCREWS	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 17, 2002	K023986	ARTHREX OPES ELECTRODES AND ACCESSORIES	GEI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 6, 2002	K020345	ARTHREX UNIVERS FRACTURE PROSTHESIS	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 6, 2001	K010124	ARTHREX UNIVERS 30 SHOULDER PROSTHESIS	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 10, 1996	K961228	KARL STORZ MAGNIFYING ARTHROSOCPES	HRX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
February 1, 1995	K943492	ARTHREX STAPLES	JDR	Substantially Equivalent for Some Indications	Arthrex, Inc.	accessdata.fda.gov
December 6, 1994	K943154	KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS	HRX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.