The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Anorganic Bone Mineral In Delivery Applicator.
| Device ID | K170541 |
| 510k Number | K170541 |
| Device Name: | Anorganic Bone Mineral In Delivery Applicator |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 |
| Contact | Danielle Lindner |
| Correspondent | Danielle Lindner 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 | 2017-02-23 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950009084 | K170541 | 000 |
| 00614950007875 | K170541 | 000 |
| 00614950007882 | K170541 | 000 |
| 00614950007905 | K170541 | 000 |
| 00614950007912 | K170541 | 000 |
| 00614950007929 | K170541 | 000 |
| 00614950007950 | K170541 | 000 |
| 00614950009053 | K170541 | 000 |
| 00614950009060 | K170541 | 000 |
| 00614950009077 | K170541 | 000 |
| 00614950007868 | K170541 | 000 |