The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prodense Bone Graft Substitute.
| Device ID | K182823 |
| 510k Number | K182823 |
| Device Name: | PRODENSE Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Alayne Melancon |
| Correspondent | Alayne Melancon Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-04 |
| Decision Date | 2018-11-02 |
| Summary: | summary |