The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Duraloc Acetabular Cup System, 36mm Marathon +4 Polyethylene Liner.
| Device ID | K010171 |
| 510k Number | K010171 |
| Device Name: | DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-18 |
| Decision Date | 2001-04-06 |