The following data is part of a premarket notification filed by Medacta International with the FDA for Mpact Extension.
| Device ID | K132879 |
| 510k Number | K132879 |
| Device Name: | MPACT EXTENSION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2014-01-22 |
| Summary: | summary |