Data / Medical devices / United States / Collagen Matrix, Inc
Collagen Matrix, Inc: FDA-registered device maker in Allendale, NJ, United States, 33 510(k) clearances
Collagen Matrix, Inc is registered with the FDA (registration 3003300673) in Allendale, NJ, United States. It lists 10 device types. The FDA files 33 510(k) clearances under its listings, the newest dated November 18, 2025. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003300673
- Address
- 110 Commerce Dr, Allendale, NJ, United States, 07401
- Owner or operator
- COLLAGEN MATRIX, INC. (9043463)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, 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-Onlay Plus, DuraMend-Onlay Plus, GUIDOR ES Membrane, GUIDOR Resorbable Matrix Barrier and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Manufacturer | accessdata.fda.gov |
| Barrier, Synthetic, Intraoral | NPK | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Contract manufacturer | accessdata.fda.gov |
| Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | OLC | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
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 |
| 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 |
| 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 |
| 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 |
| February 12, 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC | 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 |
| 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 |
| 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 |
| February 12, 1997 | K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. | GAM | Substantially Equivalent | Lukens Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 13, 2021 | 89495 | Class II | Terminated | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery | accessdata.fda.gov |
| March 19, 2019 | 82638 | Class II | Terminated | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a mate | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box | accessdata.fda.gov |
| August 16, 2018 | 81282 | Class III | Terminated | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the | accessdata.fda.gov |
| November 17, 2015 | 73208 | Class III | Terminated | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cys | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. | accessdata.fda.gov |
| August 25, 2015 | 73222 | Class II | Terminated | NuOSS Cancellous Intended for use in dental surgery. | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. | accessdata.fda.gov |
| May 13, 2013 | 73206 | Class II | Terminated | NuOss XC Sinus Reference No (BMCU17, size 17 mm diameter x 10 mm height) Reference No (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use fo | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time. | accessdata.fda.gov |
Compare with other makers
- All makers of Dura Substitute
- All makers of Bone Grafting Material, Synthetic
- All makers of Barrier, Animal Source, Intraoral
- All makers of Mesh, Surgical
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Filler, Bone Void, Calcium Compound
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.