Tutogen Medical GmBH

FDA Device Registration & Listing · Neunkirchen am Brand Bavaria, DE · Registration 3002924436

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002924436
FEI Number
3002924436
Entity Name
Tutogen Medical GmBH
City/State/Country
Neunkirchen am Brand Bavaria, DE
Establishment Address
Industriestrasse 6, Neunkirchen am Brand Bavaria D-91077, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
RTI Surgical, Inc. (dba RTI Biologics, Inc.) (Owner Number: 1641375)
Owner / Operator Contact Address
11621 Research Circle, Alachua, FL 32615, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K991296
PMA Number
N/A

All Registered Proprietary Names

Fortiva¿ porcine dermis, Tutoplast® porcine dermis Tutomesh® Bovine Pericardium Tutopatch® Bovine Pericardium Tutopatch DM Graft Tutoplast Bovine Pericardium DM Bovine Pericardium Suturable Dural Graft Tutopatch® Bovine Pericardium

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2013-04-15
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2009-08-04
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2009-08-04
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2009-08-04
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2009-08-04
GXQ Dura Substitute Neurology Class 2 882.5910 2014-04-07
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2006-03-22
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2006-03-22
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2006-03-22
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2006-03-22

Official Correspondent

Rosanne Lopez

US Agent Details

Rosanne Lopez Email: rlopez@evergenbio.com Phone: (386) 4188888

Related Public Records

Same Entity

RTI Surgical, Inc. (dba RTI Biologics, 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
3002719998 RTI Surgical, Inc. (dba RTI Biologics, Inc.) ALACHUA, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K134033 Miromatrix Medical, Inc. MIROMATRIX BIOLOGICAL MESH 2014-03-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2020 AZIYO BIOLOGICS 2
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020 AZIYO BIOLOGICS 2
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002924436. Last updated year: 2026. Please use registration number 3002924436 when referencing this establishment in official correspondence.
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