Collagen Matrix, Inc.

FDA Device Registration & Listing · Mahwah, NJ, US · Registration 3027448274

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
3027448274
FEI Number
3027448274
Entity Name
Collagen Matrix, Inc.
City/State/Country
Mahwah, NJ, US
Establishment Address
10 Industrial Ave, Mahwah, NJ 07430, US
Establishment Type(s)
Repack or Relabel Medical Device
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
K141608
PMA Number
N/A

All Registered Proprietary Names

Bovine Dermis Collagen Dermal Matrix DuraMatrix DuraMend Collatene Microfibrillar Collagen GUIDOR easy-graft CLASSIC RejuvaKnee™ Collagen Dura Regeneration Membrane - Repair NeuroMend Matrixflex X-FLEX DuraMatrix-Onlay Plus DuraMend-Onlay Plus OssiMend® Bioactive Putty OssiMend® Bioactive Strip OssiMend® Bioactive Puck TriOSS Bioactive Moldable OssiMend Bioactive Moldable OssiMend Bone Graft Matrix OssiMend Putty Bone Graft Matrix OssiMend Block Bone Graft Matrix OssiMend Conformable Putty MatrixDerm Foam MatrixDerm Plug MatrixDerm Tape Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic SynOss Granules SynOss Synthetic Bone Graft Material DuraMend-Onlay DuraMatrix-Onlay SynOss Plug NeuroFlex Rotation Medical Reconstituted Collagen Scaffold - Mini-Open MatrixOss Granules X-GEN Granules OssiMend Bioactive Moldable GUIDOR Resorbable Matrix Barrier MatrixOss Syringe X-GEN Syringe DuraMatrix Suturable DuraMend Suturable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-06-24
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-07-19
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
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-04-27
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-11-12
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-12-20
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-28
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2016-06-16
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2012-11-12
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2012-11-12
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2016-08-12
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2021-10-28
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
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2005-10-11
GXQ Dura Substitute Neurology Class 2 882.5910 2025-12-03
JXI Cuff, Nerve Neurology Class 2 882.5275 2012-11-12
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2006-10-27
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2021-04-30
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
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2013-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-07-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-05-27
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
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-03-25
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2006-10-27
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2016-08-24
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
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 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 2012-11-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2020-12-11
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-11-01
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2024-05-07
GXQ Dura Substitute Neurology Class 2 882.5910 2012-11-12
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2022-06-06
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2014-12-17
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2012-11-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2012-11-12
JXI Cuff, Nerve Neurology Class 2 882.5275 2014-12-17
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-08-17
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2015-08-17
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2014-09-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-01-10
NPK Barrier, Synthetic, Intraoral Dental Class 2 872.3930 2021-05-26
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-04-24
GXQ Dura Substitute Neurology Class 2 882.5910 2015-05-13

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
2249852 COLLAGEN MATRIX, INC. Oakland, NJ, US
3003300673 Collagen Matrix, Inc Allendale, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

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.
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027448274. Last updated year: 2026. Please use registration number 3027448274 when referencing this establishment in official correspondence.
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