Data / Medical devices / United States / Collagen Matrix, Inc.
Collagen Matrix, Inc.: FDA-registered device maker in Oakland, NJ, United States, 45 510(k) clearances
Collagen Matrix, Inc. is registered with the FDA (registration 2249852) in Oakland, NJ, United States. It lists 13 device types. The FDA files 45 510(k) clearances under its listings, the newest dated November 18, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2249852
- FEI number
- 3008817245
- Address
- 15 Thornton Rd, Oakland, NJ, United States, 07436
- Owner or operator
- COLLAGEN MATRIX, INC. (9043463)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 11, 2005
- Registered through
- 2026
- Brand names listed
- Bovine Dermis Collagen Dermal Matrix, Collagen Dura Regeneration Membrane - Repair, Collatene Microfibrillar Collagen, DurAdapt Dural Graft Implant, DuraMatrix, DuraMatrix Suturable, DuraMatrix-Onlay, DuraMatrix-Onlay Plus and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 18, 2025 | K251191 | Collagen Dura Regeneration Membrane - Repair | GXQ | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| January 6, 2025 | K241904 | DermiSphere Dermal Template | KGN | Substantially Equivalent | Fesariustherapeutics, Inc. | accessdata.fda.gov |
| December 19, 2024 | K243071 | Bovine Dermis Collagen Dermal Matrix | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 2, 2024 | K242302 | RejuvaKnee Collagen Meniscus Implant | OLC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 1, 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 12, 2024 | K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| August 2, 2023 | K231942 | Mineral Collagen Composite Bioactive Extra Moldable | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| December 20, 2022 | K221735 | Mineral Collagen Composite Bioactive Moldable | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 31, 2022 | K213341 | Fibrillar Collagen Wound Dressing | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| April 2, 2021 | K202183 | Porcine Mineral Collagen Composite | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| September 11, 2020 | K201859 | Porcine Mineral Collagen Composite Moldable | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 21, 2019 | K182074 | Mineral Collagen Composite Bioactive Moldable | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 30, 2017 | K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 7, 2017 | K170541 | Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| February 9, 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| June 23, 2016 | K152600 | Collagen Dental Wound Dressings | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| November 20, 2015 | K150825 | Collagen Dural Regeneration Matrix | GXQ | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 30, 2015 | K152481 | DURAFORM Dural Graft Implant | GXQ | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| September 15, 2015 | K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | NPL | Substantially Equivalent | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | accessdata.fda.gov |
| January 16, 2015 | K141608 | COLLAGEN DURA MEMBRANE | GXQ | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| November 24, 2014 | K142496 | Collagen Dental Membrane - Conformable IIBP | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| November 5, 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 16, 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| April 3, 2014 | K131541 | FLEXIBLE COOAGEN NERVE CUFF | JXI | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 29, 2013 | K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | NPK | Substantially Equivalent | Sunstar Americas, Inc. | accessdata.fda.gov |
| September 27, 2013 | K131385 | EASY-GRAFT | LYC | Substantially Equivalent | Degradable Solutions AG | accessdata.fda.gov |
| November 1, 2012 | K122115 | COLLAGEN DENTAL WOUND DRESSINGS | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 29, 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| August 11, 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| September 18, 2009 | K090216 | COLLAGEN DENTAL MEMBRANE IV | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| February 12, 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 15, 2008 | K080452 | COLLAGEN TENDON WRAP | FTM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 18, 2007 | K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 11, 2006 | K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 14, 2006 | K060952 | COLLAGEN NERVE WRAP | JXI | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| June 26, 2006 | K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE | GXQ | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| January 25, 2006 | K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| August 4, 2005 | K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| December 1, 2004 | K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE | GXQ | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 10, 2004 | K040403 | COLLAGEN WOUND DRESSING - ORAL | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 17, 2004 | K033729 | COLLAGEN DENTAL WOUND DRESSINGS | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| September 21, 2001 | K012814 | COLLAGEN NERVE CUFF | JXI | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| August 7, 2001 | K011695 | COLLAGEN DENTAL MEMBRANE | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| January 8, 2001 | K003339 | COLLAGEN PERIODONTAL MEMBRANE | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 3, 2022 | 90783 | Class II | Ongoing | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0. | The packaging may not be sealed, which could compromise sterility. | accessdata.fda.gov |
| November 5, 2019 | 84334 | Class II | Terminated | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate e | The products may have been packaged with an incorrect Instructions for Use. | accessdata.fda.gov |
| October 30, 2018 | 81626 | Class III | Terminated | Porcine Anorganic Bone Mineral 4.0cc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier, Synthetic, Intraoral
- All makers of Dura Substitute
- All makers of Mesh, Surgical
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical, Deployer
- All makers of Barrier, Animal Source, Intraoral
Updated November 18, 2025. 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.