The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Miig Ii Bone Graft Substitute.
| Device ID | K024336 |
| 510k Number | K024336 |
| Device Name: | MIIG II BONE GRAFT SUBSTITUTE |
| 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 | 2002-12-27 |
| Decision Date | 2003-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420140807 | K024336 | 000 |
| 00840420134141 | K024336 | 000 |
| 00840420134165 | K024336 | 000 |
| 00840420134172 | K024336 | 000 |
| 00840420134363 | K024336 | 000 |
| 00840420134370 | K024336 | 000 |
| 00840420134936 | K024336 | 000 |
| 00840420135544 | K024336 | 000 |
| 00840420135551 | K024336 | 000 |
| 00840420134134 | K024336 | 000 |