Collagen Matrix, Inc

FDA Device Registration & Listing · Allendale, NJ, US · Registration 3003300673

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
3003300673
FEI Number
3003300673
Entity Name
Collagen Matrix, Inc
City/State/Country
Allendale, NJ, US
Establishment Address
110 Commerce Dr, Allendale, NJ 07401, US
Establishment Type(s)
Manufacture 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
K242302
PMA Number
N/A

All Registered Proprietary Names

GUIDOR easy-graft CLASSIC TriOSS Bioactive Moldable OssiMend Bioactive Moldable OssiMend® Bioactive Putty OssiMend® Bioactive Strip OssiMend® Bioactive Puck Matrixflex X-FLEX MatrixMem Regenerative Collagen Dental Membrane Collatene Microfibrillar Collagen Guidor easy-graft CRYSTAL+ Guidor easy-graft CLASSIC+ Guidor easy-graft CLASSIC Guidor easy-graft CRYSTAL OssiMend Bioactive Moldable GUIDOR Resorbable Matrix Barrier MatrixOss Granules X-GEN Granules DuraMatrix-Onlay Plus DuraMend-Onlay Plus DurAdapt Dural Graft Implant MatrixOss Syringe X-GEN Syringe GUIDOR ES Membrane Collagen Dura Regeneration Membrane - Repair MatrixDerm Foam MatrixDerm Plug MatrixDerm Tape RejuvaKnee™

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2021-10-28
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 2022-06-06
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 2024-07-31
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2014-12-17
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 2012-11-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-11-01
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2022-08-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-09-25
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2020-12-11
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
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2016-08-12
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-07-19
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-04-27
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2014-09-16
GXQ Dura Substitute Neurology Class 2 882.5910 2016-02-04
GXQ Dura Substitute Neurology Class 2 882.5910 2022-07-11
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2013-06-24
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-04-24
NPK Barrier, Synthetic, Intraoral Dental Class 2 872.3930 2022-07-01
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
GXQ Dura Substitute Neurology Class 2 882.5910 2025-12-03
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2005-10-11
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 2016-08-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-05-27
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

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
3027448274 Collagen Matrix, Inc. Mahwah, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K052493 Steiner Laboratories SOCKET GRAFT 2006-06-09
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
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

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 3003300673. Last updated year: 2026. Please use registration number 3003300673 when referencing this establishment in official correspondence.
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