Company · US
Collagen Matrix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (1 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | 17 |
| NPM | Bone Grafting Material, Animal Source | 11 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 9 |
| GXQ | Dura Substitute | 7 |
| MQV | Filler, Bone Void, Calcium Compound | 7 |
| JXI | Cuff, Nerve | 4 |
| LYC | Bone Grafting Material, Synthetic | 4 |
| FTM | Mesh, Surgical | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2025 | K251191 | Collagen Dura Regeneration Membrane - Repair Collagen Matrix, Inc. | GXQ |
| Dec 19, 2024 | K243071 | Bovine Dermis Collagen Dermal Matrix Collagen Matrix, Inc. | KGN |
| Oct 2, 2024 | K242302 | RejuvaKnee Collagen Meniscus Implant Collagen Matrix, Inc. | OLC |
| May 1, 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix Collagen Matrix, Inc. | NPL |
| Mar 12, 2024 | K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix Collagen Matrix, Inc. | MQV |
| Aug 2, 2023 | K231942 | Mineral Collagen Composite Bioactive Extra Moldable Collagen Matrix, Inc. | MQV |
| Dec 20, 2022 | K221735 | Mineral Collagen Composite Bioactive Moldable Collagen Matrix, Inc. | MQV |
| May 31, 2022 | K213341 | Fibrillar Collagen Wound Dressing Collagen Matrix, Inc. | KGN |
| Apr 2, 2021 | K202183 | Porcine Mineral Collagen Composite Collagen Matrix, Inc. | NPM |
| Sep 11, 2020 | K201859 | Porcine Mineral Collagen Composite Moldable Collagen Matrix, Inc. | NPM |
| Mar 21, 2019 | K182074 | Mineral Collagen Composite Bioactive Moldable Collagen Matrix, Inc. | MQV |
| Oct 30, 2017 | K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator Collagen Matrix, Inc. | NPM |
| Jul 7, 2017 | K170541 | Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. | NPM |
| Jun 1, 2017 | K170656 | Reinforced Flexible Collagen Nerve Cuff Collagen Matrix, Inc. | JXI |
| Feb 9, 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. | NPM |
| Jun 23, 2016 | K152600 | Collagen Dental Wound Dressings Collagen Matrix, Inc. | KGN |
| Nov 20, 2015 | K150825 | Collagen Dural Regeneration Matrix Collagen Matrix, Inc. | GXQ |
| Jan 16, 2015 | K141608 | COLLAGEN DURA MEMBRANE Collagen Matrix, Inc. | GXQ |
| Nov 24, 2014 | K142496 | Collagen Dental Membrane - Conformable IIBP Collagen Matrix, Inc. | NPL |
| Nov 5, 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP Collagen Matrix, Inc. | NPL |
| Jul 16, 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL Collagen Matrix, Inc. | NPM |
| Apr 3, 2014 | K131541 | FLEXIBLE COOAGEN NERVE CUFF Collagen Matrix, Inc. | JXI |
| Nov 1, 2012 | K122115 | COLLAGEN DENTAL WOUND DRESSINGS Collagen Matrix, Inc. | KGN |
| Jul 29, 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN Collagen Matrix, Inc. | NPL |
| Aug 11, 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V Collagen Matrix, Inc. | NPL |
| May 28, 2010 | K092608 | SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX Collagen Matrix, Inc. | MQV |
| Sep 18, 2009 | K090216 | COLLAGEN DENTAL MEMBRANE IV Collagen Matrix, Inc. | NPL |
| Feb 12, 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX Collagen Matrix, Inc. | LYC |
| May 15, 2008 | K080452 | COLLAGEN TENDON WRAP Collagen Matrix, Inc. | FTM |
| Oct 18, 2007 | K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL Collagen Matrix, Inc. | LYC |
| Feb 13, 2007 | K062200 | COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS Collagen Matrix, Inc. | MQV |
| Oct 13, 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III Collagen Matrix, Inc. | NPL |
| Oct 11, 2006 | K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II Collagen Matrix, Inc. | NPL |
| Jul 14, 2006 | K060952 | COLLAGEN NERVE WRAP Collagen Matrix, Inc. | JXI |
| Jun 26, 2006 | K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE Collagen Matrix, Inc. | GXQ |
| Jan 25, 2006 | K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL Collagen Matrix, Inc. | MQV |
| Oct 25, 2005 | K052041 | COLLAGEN BONE HEALING PROTECTIVE SHEET Collagen Matrix, Inc. | HRS |
| Aug 4, 2005 | K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS Collagen Matrix, Inc. | NPM |
| Dec 1, 2004 | K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE Collagen Matrix, Inc. | GXQ |
| May 10, 2004 | K040403 | COLLAGEN WOUND DRESSING - ORAL Collagen Matrix, Inc. | KGN |
| Mar 17, 2004 | K040558 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING Collagen Matrix, Inc. | KGN |
| Mar 17, 2004 | K033729 | COLLAGEN DENTAL WOUND DRESSINGS Collagen Matrix, Inc. | LYC |
| Feb 27, 2004 | K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING Collagen Matrix, Inc. | KGN |
| May 15, 2003 | K030921 | COLLAGEN TOPICAL WOUND DRESSING Collagen Matrix, Inc. | KGN |
| Sep 21, 2001 | K012814 | COLLAGEN NERVE CUFF Collagen Matrix, Inc. | JXI |
| Aug 7, 2001 | K011695 | COLLAGEN DENTAL MEMBRANE Collagen Matrix, Inc. | NPL |
| Jan 8, 2001 | K003339 | COLLAGEN PERIODONTAL MEMBRANE Collagen Matrix, Inc. | NPL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2022 | Collagen Matrix Inc 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) Maxx Open, Classified |
KGN | K152600 |
| Feb 24, 2022 | Collagen Matrix, Inc. RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter.
REF: DUMO10125 Terminated |
GXQ | K061487 |
| Feb 24, 2022 | Collagen Matrix, Inc. DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)
REF: CDSLM45 Terminated |
GXQ | K061487 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around imp Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc 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 p Terminated |
NPL | K100156 |
| Mar 19, 2019 | Collagen Matrix, Inc. 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 Terminated |
NPL | K003339 K011695 |
| Nov 9, 2018 | Collagen Matrix, Inc. BioMend Extend, REF# 0142Z, Synthetic bone grafting material. Terminated |
LYC | K062846 |
| Oct 30, 2018 | Collagen Matrix Inc Porcine Anorganic Bone Mineral 4.0cc Terminated |
NPM | K140714 |
| Mar 11, 2016 | Collagen Matrix Inc NuOss XC Sinus
Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)
Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)
Manufacturer:- Collagen Matrix,
Distributor:- ACE Terminated |
NPM | K043034 |
| Nov 17, 2015 | Collagen Matrix Inc 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 Terminated |
NPM | K140714 |
| Aug 25, 2015 | Collagen Matrix Inc NuOSS Cancellous
Intended for use in dental surgery. Terminated |
NPM | K043034 |