The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M-vizion Femoral Revision System.
| Device ID | K170690 |
| 510k Number | K170690 |
| Device Name: | M-Vizion Femoral Revision System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Elizabeth Rose Mapi USA, Inc 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030885143 | K170690 | 000 |
| 07630030884986 | K170690 | 000 |
| 07630030884993 | K170690 | 000 |
| 07630030885006 | K170690 | 000 |
| 07630030885013 | K170690 | 000 |
| 07630030885020 | K170690 | 000 |
| 07630030885037 | K170690 | 000 |
| 07630030885044 | K170690 | 000 |
| 07630030885051 | K170690 | 000 |
| 07630030885068 | K170690 | 000 |
| 07630030885075 | K170690 | 000 |
| 07630030885082 | K170690 | 000 |
| 07630030885099 | K170690 | 000 |
| 07630030885105 | K170690 | 000 |
| 07630030885112 | K170690 | 000 |
| 07630030885136 | K170690 | 000 |
| 07630030877148 | K170690 | 000 |