The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prostim Injectable Inductive Graft.
| Device ID | K190283 |
| 510k Number | K190283 |
| Device Name: | PROSTIM Injectable Inductive Graft |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Rachel Roberts |
| Correspondent | Rachel Roberts 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 | 2019-02-11 |
| Decision Date | 2019-03-14 |