The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Plasmafit Acetabular Cup And Vitelene Insert.
| Device ID | K122783 |
| 510k Number | K122783 |
| Device Name: | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Julie Tom Wing |
| Correspondent | Julie Tom Wing AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | OQG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-11 |
| Decision Date | 2013-10-30 |
| Summary: | summary |