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Arthrex GMBH: FDA-registered device maker in Odelzhausen Bavaria, Germany, 3 510(k) clearances

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

Arthrex GMBH is registered with the FDA (registration 3007193505) in Odelzhausen Bavaria, Germany. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 22, 2018. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007193505
Address: Oskar-von-Miller Strasse 6, Odelzhausen Bavaria, Germany, 85235
Owner or operator: ARTHREX, INC. (1220287)
Roles: Exporter to the US
First device listed: January 27, 1994
Registered through: 2027
Brand names listed: ANATOEMIC PROSTHESIS, ARTHREX ANATOEMIC P, CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO, Camera Heads, DOUBLE SYRINGE (ACP) SYSTEM, HATRIC, INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT, Instrument, manual, surgical, general use and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Camera, Cine, Endoscopic, Without Audio	FWL	1	Exporter to the US	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Exporter to the US	accessdata.fda.gov
Gauge, Depth	HTJ	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Prosthesis, Toe, Hemi-, Phalangeal	KWD	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	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
June 22, 2018	K180594	Knotless SutureTak Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 3, 2007	K063058	ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS	KWD	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 12, 2004	K040381	HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15	MQV	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 22, 2018. 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.