The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Duraloc Cementless Acetabular Cup System.
| Device ID | K951301 |
| 510k Number | K951301 |
| Device Name: | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Steve Wentworth |
| Correspondent | Steve Wentworth 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 | 1995-03-22 |
| Decision Date | 1995-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295019831 | K951301 | 000 |
| 10603295019657 | K951301 | 000 |
| 10603295019664 | K951301 | 000 |
| 10603295019671 | K951301 | 000 |
| 10603295019749 | K951301 | 000 |
| 10603295019756 | K951301 | 000 |
| 10603295019763 | K951301 | 000 |
| 10603295019770 | K951301 | 000 |
| 10603295019787 | K951301 | 000 |
| 10603295019794 | K951301 | 000 |
| 10603295019800 | K951301 | 000 |
| 10603295019817 | K951301 | 000 |
| 10603295019824 | K951301 | 000 |
| 10603295019640 | K951301 | 000 |