The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ignite Bone Void Filler.
| Device ID | K190482 |
| 510k Number | K190482 |
| Device Name: | IGNITE Bone Void Filler |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797076029 | K190482 | 000 |
| 00889797076036 | K190482 | 000 |
| 00889797076012 | K190482 | 000 |
| 00889797076005 | K190482 | 000 |