Oakland, NJ, US · 10 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 3 | 2024-03-12 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | Unknown | 2 | 2024-12-19 |
| NPM | Bone Grafting Material, Animal Source | Class II | Dental | 2 | 2021-04-02 |
| GXQ | Dura Substitute | Class II | Neurology | 1 | 2025-11-18 |
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | Class II | General, Plastic Surgery | 1 | 2024-10-02 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | 1 | 2024-05-01 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-08-03 | Class II | Ongoing | Z-1777-2022 | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand nam… | — | The packaging may not be sealed, which could compromise sterility. |
| 2021-12-13 | Class II | Terminated | Z-0669-2022 | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125 | — | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| 2021-12-13 | Class II | Terminated | Z-0668-2022 | 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 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-18 | K251191 | Collagen Dura Regeneration Membrane - Repair | GXQ | Class II | Neurology |
| 2024-12-19 | K243071 | Bovine Dermis Collagen Dermal Matrix | KGN | Unclassified | Unknown |
| 2024-10-02 | K242302 | RejuvaKnee Collagen Meniscus Implant | OLC | Class II | General, Plastic Surgery |
| 2024-05-01 | K233203 | Soft Tissue Augmentation Resorbable Matrix | NPL | Class II | Dental |
| 2024-03-12 | K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | MQV | Class II | Orthopedic |
| 2023-08-02 | K231942 | Mineral Collagen Composite Bioactive Extra Moldable | MQV | Class II | Orthopedic |
| 2022-12-20 | K221735 | Mineral Collagen Composite Bioactive Moldable | MQV | Class II | Orthopedic |
| 2022-05-31 | K213341 | Fibrillar Collagen Wound Dressing | KGN | Unclassified | Unknown |
| 2021-04-02 | K202183 | Porcine Mineral Collagen Composite | NPM | Class II | Dental |
| 2020-09-11 | K201859 | Porcine Mineral Collagen Composite Moldable | NPM | Class II | Dental |