The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Duraloc 100c Acetabular Cup.
| Device ID | K951674 |
| 510k Number | K951674 |
| Device Name: | DEPUY DURALOC 100C ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Lorell E Lauer |
| Correspondent | Lorell E Lauer DEPUY, INC. P.O. BOX 988 700 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 | 1995-04-11 |
| Decision Date | 1995-05-11 |