The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-dense Lovisc Bone Graft Substitute.
| Device ID | K213342 |
| 510k Number | K213342 |
| Device Name: | PRO-DENSE LoVisc Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-07 |
| Decision Date | 2022-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797109796 | K213342 | 000 |
| 00889797103589 | K213342 | 000 |
| 00889797080415 | K213342 | 000 |
| 00889797080392 | K213342 | 000 |