Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Collagen Matrix, Inc. — Predicate Candidate Screening
47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
241 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025-11-18 | 215 | 0 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024-12-19 | 83 | 0 |
| K242302 | RejuvaKnee™ Collagen Meniscus Implant | Collagen Matrix, Inc. | 2024-10-02 | 58 | 0 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | 2024-05-01 | 216 | 0 |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Mat | Collagen Matrix, Inc. | 2024-03-12 | 28 | 0 |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Collagen Matrix, Inc. | 2023-08-02 | 33 | 0 |
| K221735 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2022-12-20 | 188 | 0 |
| K213341 | Fibrillar Collagen Wound Dressing | Collagen Matrix, Inc. | 2022-05-31 | 236 | 0 |
| K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | 2021-04-02 | 241 | 0 |
| K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | 2020-09-11 | 67 | 0 |
| K182074 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2019-03-21 | 232 | 0 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | 2017-10-30 | 209 | 0 |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-07-07 | 134 | 0 |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | 2017-06-01 | 90 | 0 |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-02-09 | 191 | 0 |
| K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2016-06-23 | 286 | 1 |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | 2015-11-20 | 238 | 0 |
| K141608 | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | 2015-01-16 | 214 | 0 |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | 2014-11-24 | 80 | 0 |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | 2014-11-05 | 113 | 0 |
| K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | 2014-07-16 | 117 | 0 |
| K131541 | FLEXIBLE COOAGEN NERVE CUFF | Collagen Matrix, Inc. | 2014-04-03 | 309 | 0 |
| K122115 | COLLAGEN DENTAL WOUND DRESSINGS | Collagen Matrix, Inc. | 2012-11-01 | 107 | 0 |
| K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | 2011-07-29 | 149 | 0 |
| K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | 2010-08-11 | 203 | 0 |
| K092608 | SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | 2010-05-28 | 276 | 0 |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | Collagen Matrix, Inc. | 2009-09-18 | 232 | 0 |
| K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | 2009-02-12 | 58 | 0 |
| K080452 | COLLAGEN TENDON WRAP | Collagen Matrix, Inc. | 2008-05-15 | 86 | 0 |
| K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | Collagen Matrix, Inc. | 2007-10-18 | 52 | 0 |
| K062200 | COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS | Collagen Matrix, Inc. | 2007-02-13 | 196 | 0 |
| K062846 | COLLAGEN DENTAL MEMBRANE III | Collagen Matrix, Inc. | 2006-10-13 | 21 | 1 |
| K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | Collagen Matrix, Inc. | 2006-10-11 | 15 | 0 |
| K060952 | COLLAGEN NERVE WRAP | Collagen Matrix, Inc. | 2006-07-14 | 99 | 0 |
| K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUT | Collagen Matrix, Inc. | 2006-06-26 | 26 | 2 |
| K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL | Collagen Matrix, Inc. | 2006-01-25 | 113 | 0 |
| K052041 | COLLAGEN BONE HEALING PROTECTIVE SHEET | Collagen Matrix, Inc. | 2005-10-25 | 89 | 0 |
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | Collagen Matrix, Inc. | 2005-08-04 | 274 | 1 |
| K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE | Collagen Matrix, Inc. | 2004-12-01 | 240 | 0 |
| K040403 | COLLAGEN WOUND DRESSING - ORAL | Collagen Matrix, Inc. | 2004-05-10 | 83 | 0 |
| K040558 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | Collagen Matrix, Inc. | 2004-03-17 | 14 | 0 |
| K033729 | COLLAGEN DENTAL WOUND DRESSINGS | Collagen Matrix, Inc. | 2004-03-17 | 110 | 0 |
| K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | Collagen Matrix, Inc. | 2004-02-27 | 28 | 0 |
| K030921 | COLLAGEN TOPICAL WOUND DRESSING | Collagen Matrix, Inc. | 2003-05-15 | 52 | 0 |
| K012814 | COLLAGEN NERVE CUFF | Collagen Matrix, Inc. | 2001-09-21 | 30 | 0 |
| K011695 | COLLAGEN DENTAL MEMBRANE | Collagen Matrix, Inc. | 2001-08-07 | 68 | 0 |
| K003339 | COLLAGEN PERIODONTAL MEMBRANE | Collagen Matrix, Inc. | 2001-01-08 | 75 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda