The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ignite Bone Void Filler Kit.
| Device ID | K052913 |
| 510k Number | K052913 |
| Device Name: | IGNITE BONE VOID FILLER KIT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ehab M Esmail |
| Correspondent | Ehab M Esmail WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-17 |
| Decision Date | 2005-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420135162 | K052913 | 000 |
| 00840420135155 | K052913 | 000 |
| 00840420133694 | K052913 | 000 |