The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Porcine Mineral Collagen Composite.
| Device ID | K202183 |
| 510k Number | K202183 |
| Device Name: | Porcine Mineral Collagen Composite |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 |
| Contact | Gloria Zuclich |
| Correspondent | Gloria Zuclich Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2021-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D765ZXSOCKET0 | K202183 | 000 |
| D765ZXSINUSS0 | K202183 | 000 |
| D765ZXSINUSL0 | K202183 | 000 |