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Tutogen Medical GmBH: FDA-registered device maker in Neunkirchen am Brand Bavaria, Germany, 7 510(k) clearances

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

Tutogen Medical GmBH is registered with the FDA (registration 3002924436) in Neunkirchen am Brand Bavaria, Germany. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 27, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002924436
Address: Industriestrasse 6, Neunkirchen am Brand Bavaria, Germany, D-91077
Owner or operator: RTI Surgical, Inc. (dba RTI Biologics, Inc.) (1641375)
Roles: Manufacturer
First device listed: March 22, 2006
Registered through: 2026
Brand names listed: Bovine Pericardium, Bovine Pericardium Suturable Dural Graft, CopiOs® Pericardium Membrane, Fortiva Porcine Dermis, Fortiva¿ porcine dermis, Tutoplast® porcine dermis, Tutodent® membrane, Tutomesh® Bovine Pericardium, Tutopatch DM Graft and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Animal Source, Intraoral	NPL	2	Manufacturer	accessdata.fda.gov
Dura Substitute	GXQ	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	OXF	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Manufacturer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	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
October 27, 2014	K142070	FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS	FTM	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
March 31, 2014	K132850	BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM	GXQ	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
March 5, 2013	K123356	FORTIVA PORCINE DERMIS	FTM	Substantially Equivalent	Rti Biologics, Inc.	accessdata.fda.gov
August 31, 2009	K091142	TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358	FTM	Substantially Equivalent	Rti Biologics, Inc.	accessdata.fda.gov
June 19, 2008	K081538	TUTOPATCH, TUTOMESH	FTM	Substantially Equivalent	Rti Biologics, Inc.	accessdata.fda.gov
May 12, 2008	K073097	TUTODENT DENTAL MEMBRANE	NPL	Substantially Equivalent	Tutogen Medical U.S., Inc.	accessdata.fda.gov
October 6, 2000	K991296	TUTOPATCH	FTM	Substantially Equivalent	Tutogen Medical U.S., Inc.	accessdata.fda.gov

Compare with other makers

Updated October 27, 2014. 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.