The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Vitalite E Cross-linked Polyethylene Acetabular Insert.
| Device ID | K130652 |
| 510k Number | K130652 |
| Device Name: | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Contact | Matthew Hull |
| Correspondent | Matthew Hull CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Product Code | OQG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| 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 | 2013-03-12 |
| Decision Date | 2013-12-17 |
| Summary: | summary |