The following data is part of a premarket notification filed by Medacta International with the FDA for Mpact Dm Liner Converter.
| Device ID | K131458 |
| 510k Number | K131458 |
| Device Name: | MPACT DM LINER CONVERTER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030812354 | K131458 | 000 |
| 07630030812347 | K131458 | 000 |
| 07630030812330 | K131458 | 000 |
| 07630030812323 | K131458 | 000 |
| 07630030812200 | K131458 | 000 |
| 07630030812095 | K131458 | 000 |
| 07630030806803 | K131458 | 000 |
| 07630030806797 | K131458 | 000 |