The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Duofix Ha Acetabular Cup Prosthesis.
| Device ID | K031495 |
| 510k Number | K031495 |
| Device Name: | PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Karla A Ham |
| Correspondent | Karla A Ham DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-13 |
| Decision Date | 2003-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295009238 | K031495 | 000 |
| 10603295009122 | K031495 | 000 |
| 10603295009115 | K031495 | 000 |
| 10603295009108 | K031495 | 000 |
| 10603295009092 | K031495 | 000 |
| 10603295009085 | K031495 | 000 |
| 10603295009078 | K031495 | 000 |
| 10603295009061 | K031495 | 000 |
| 10603295009054 | K031495 | 000 |
| 10603295009139 | K031495 | 000 |
| 10603295009146 | K031495 | 000 |
| 10603295009221 | K031495 | 000 |
| 10603295009214 | K031495 | 000 |
| 10603295009207 | K031495 | 000 |
| 10603295009191 | K031495 | 000 |
| 10603295009184 | K031495 | 000 |
| 10603295009177 | K031495 | 000 |
| 10603295009160 | K031495 | 000 |
| 10603295009153 | K031495 | 000 |
| 10603295009047 | K031495 | 000 |