Collagen Matrix, Inc.
Medical device manufacturer in Oakland, NJ.
47510(k) clearances
0PMA approvals
15recalls
Device types
- NPL Barrier, Animal Source, Intraoral 10
- KGN Wound Dressing With Animal-Derived… 8
- NPM Bone Grafting Material, Animal Source 7
- MQV Filler, Bone Void, Calcium Compound 7
- GXQ Dura Substitute 5
- JXI Cuff, Nerve 4
- LYC Bone Grafting Material, Synthetic 3
- HRS Plate, Fixation, Bone 1
- FTM Mesh, Surgical 1
- OLC Scaffold, Partial Medial Meniscal Defects… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | 11/18/2025SE |
| K243071 | Bovine Dermis Collagen Dermal MatrixKGN · Traditional | 12/19/2024SE |
| K242302 | RejuvaKnee Collagen Meniscus ImplantOLC · Traditional | 10/02/2024SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | 05/01/2024SE |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMQV · Traditional | 03/12/2024SE |
| K231942 | Mineral Collagen Composite Bioactive Extra MoldableMQV · Special | 08/02/2023SE |
| K221735 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 12/20/2022SE |
| K213341 | Fibrillar Collagen Wound DressingKGN · Traditional | 05/31/2022SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | 04/02/2021SE |
| K201859 | Porcine Mineral Collagen Composite MoldableNPM · Traditional | 09/11/2020SE |
| K182074 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 03/21/2019SE |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery ApplicatorNPM · Traditional | 10/30/2017SE |
| K170541 | Anorganic Bone Mineral in Delivery ApplicatorNPM · Traditional | 07/07/2017SE |
| K170656 | Reinforced Flexible Collagen Nerve CuffJXI · Traditional | 06/01/2017SE |
| K162158 | Porcine Anorganic Bone Mineral in Delivery ApplicatorNPM · Traditional | 02/09/2017SE |
| K152600 | Collagen Dental Wound DressingsKGN · Traditional | 06/23/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | 11/20/2015SE |
| K141608 | Collagen Dura MembraneGXQ · Traditional | 01/16/2015SE |
| K142496 | Collagen Dental Membrane - Conformable IIBPNPL · Traditional | 11/24/2014SE |
| K141909 | Collagen Dental Membrane - Conformable PPNPL · Traditional | 11/05/2014SE |
| K140714 | Porcine Anorganic Bone MineralNPM · Traditional | 07/16/2014SE |
| K131541 | Flexible Cooagen Nerve CuffJXI · Traditional | 04/03/2014SE |
| K122115 | Collagen Dental Wound DressingsKGN · Traditional | 11/01/2012SE |
| K110600 | Collagen Dental Mambrane - Porcine Type I CollagenNPL · Traditional | 07/29/2011SE |
| K100156 | Collagen Dental Membrane VNPL · Traditional | 08/11/2010SE |
| K092608 | Synthetic Mineral-Collagen Bone Graft MatrixMQV · Traditional | 05/28/2010SE |
| K090216 | Collagen Dental Membrane IVNPL · Traditional | 09/18/2009SE |
| K083742 | Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixLYC · Traditional | 02/12/2009SE |
| K080452 | Collagen Tendon WrapFTM · Traditional | 05/15/2008SE |
| K072397 | Synoss Synthetic Bone Graft MaterialLYC · Traditional | 10/18/2007SE |
| K062200 | Collagen Matrix Anorganic Bone Mineral Bone Graft MaterialsMQV · Traditional | 02/13/2007SE |
| K062846 | Collagen Dental Membrane IIINPL · Special | 10/13/2006SE |
| K062881 | Collagen Dental Menbrane - Conformable IINPL · Special | 10/11/2006SE |
| K060952 | Collagen Nerve WrapJXI · Traditional | 07/14/2006SE |
| K061487 | Duramatrix Collagen Dura Substitute Membrane - Onlay and SuturableGXQ · Special | 06/26/2006SE |
| K052812 | Ossimend (TM) Bone Graft MaterialMQV · Traditional | 01/25/2006SE |
| K052041 | Collagen Bone Healing Protective SheetHRS · Traditional | 10/25/2005SE |
| K043034 | Osteoguide Anorganic Bone Mineral ProductsNPM · Traditional | 08/04/2005SE |
| K040888 | Duramatrix Collagen Dura Substitute MembraneGXQ · Traditional | 12/01/2004SE |
| K040403 | Collagen Wound Dressing - OralKGN · Traditional | 05/10/2004SE |
| K040558 | Modification to: Collagen Topical Wound DressingKGN · Special | 03/17/2004SE |
| K033729 | Collagen Dental Wound DressingsLYC · Traditional | 03/17/2004SE |
| K040211 | Modification to: Collagen Topical Wound DressingKGN · Special | 02/27/2004SE |
| K030921 | Collagen Topical Wound DressingKGN · Traditional | 05/15/2003SE |
| K012814 | Collagen Nerve CuffJXI · Traditional | 09/21/2001SE |
| K011695 | Collagen Dental MembraneNPL · Traditional | 08/07/2001SE |
| K003339 | Collagen Periodontal MembraneNPL · Traditional | 01/08/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1777-2022 Class II | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed…The packaging may not be sealed, which could compromise sterility. | 08/03/2022Open, Classified |
| Z-0669-2022 Class II | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair…Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient… | 12/13/2021Terminated |
| Z-0668-2022 Class II | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)…Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient… | 12/13/2021Terminated |
| Z-0912-2020 Class II | GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-0911-2020 Class II | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-0910-2020 Class II | GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-0909-2020 Class II | GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-0908-2020 Class II | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-0907-2020 Class II | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | 11/05/2019Terminated |
| Z-1389-2019 Class II | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 -…Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem… | 03/19/2019Terminated |
| Z-0752-2019 Class III | Porcine Anorganic Bone Mineral 4.0ccThere is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is… | 10/30/2018Terminated |
| Z-0414-2019 Class III | 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… | 08/16/2018Terminated |
| Z-1173-2016 Class III | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental…The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and… | 11/17/2015Terminated |
| Z-1096-2016 Class II | 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… | 08/25/2015Terminated |
| Z-1097-2016 Class II | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)…During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year… | 05/13/2013Terminated |