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 | K181255 |
| 510k Number | K181255 |
| Device Name: | PRODENSE Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Contact | Rachel Roberts |
| Correspondent | Rachel Roberts Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797072731 | K181255 | 000 |
| 00889797073318 | K181255 | 000 |
| 00889797073301 | K181255 | 000 |
| 00889797072762 | K181255 | 000 |
| 00889797072755 | K181255 | 000 |
| 00889797072748 | K181255 | 000 |
| 00889797072724 | K181255 | 000 |
| 00889797072717 | K181255 | 000 |
| 00889797072700 | K181255 | 000 |