COLLAGEN MATRIX, INC.

FDA Device Registration & Listing · Oakland, NJ, US · Registration 2249852

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
2249852
FEI Number
3008817245
Entity Name
COLLAGEN MATRIX, INC.
City/State/Country
Oakland, NJ, US
Establishment Address
15 Thornton Rd, Oakland, NJ 07436, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
COLLAGEN MATRIX, INC. (Owner Number: 9043463)
Owner / Operator Contact Address
15 Thornton Rd, --, Oakland, NJ 07436, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K162158
PMA Number
N/A

All Registered Proprietary Names

Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic MatrixOss Granules X-GEN Granules NeuroFlex DuraMend-Onlay DuraMatrix-Onlay Collatene Microfibrillar Collagen MatrixDerm Foam MatrixDerm Plug MatrixDerm Tape OssiMend Bioactive Moldable NeuroMatrix NeuroFlex OssiMend® Bioactive Putty OssiMend® Bioactive Strip OssiMend® Bioactive Puck DuraMatrix Suturable DuraMend Suturable SynOss Granules SynOss Synthetic Bone Graft Material Collagen Dura Regeneration Membrane - Repair Matrixflex X-FLEX DuraMatrix-Onlay Plus DuraMend-Onlay Plus RejuvaKnee™ DuraMatrix DuraMend TenoMend NeuroMend MatrixOss Syringe X-GEN Syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2015-08-17
ORQ Mesh, Surgical, Deployer General, Plastic Surgery Class 2 878.3300 2015-08-17
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2014-09-16
JXI Cuff, Nerve Neurology Class 2 882.5275 2014-12-17
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2006-10-27
GXQ Dura Substitute Neurology Class 2 882.5910 2012-11-12
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2012-11-12
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2025-04-03
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2025-04-03
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2024-05-07
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2022-06-06
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2005-10-11
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2016-08-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-01-10
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-28
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-07-31
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-11-12
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-11-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2020-12-11
GXQ Dura Substitute Neurology Class 2 882.5910 2015-05-13
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2013-06-24
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-11-12
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-28
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-04-27
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2021-04-30
GXQ Dura Substitute Neurology Class 2 882.5910 2025-12-03
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2009-10-16
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2014-12-17
GXQ Dura Substitute Neurology Class 2 882.5910 2016-02-04
OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen General, Plastic Surgery Class 2 878.3300 2024-10-25
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-28
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2016-08-12
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2009-10-16
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2012-11-12
JXI Cuff, Nerve Neurology Class 2 882.5275 2012-11-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COLLAGEN MATRIX, 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
3027448274 Collagen Matrix, Inc. Mahwah, NJ, US
3003300673 Collagen Matrix, Inc Allendale, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K121139 Covidien, LLC ACCUMESH DEPLOYMENT SYSTEM 2012-05-02
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K134033 Miromatrix Medical, Inc. MIROMATRIX BIOLOGICAL MESH 2014-03-31
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11

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 2249852. Last updated year: 2026. Please use registration number 2249852 when referencing this establishment in official correspondence.
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