The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Revision System.
| Device ID | K033338 |
| 510k Number | K033338 |
| Device Name: | PINNACLE REVISION SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Bob Friddle |
| Correspondent | Bob Friddle 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 | 2003-10-17 |
| Decision Date | 2004-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295009726 | K033338 | 000 |
| 10603295008835 | K033338 | 000 |
| 10603295008828 | K033338 | 000 |
| 10603295008811 | K033338 | 000 |
| 10603295008804 | K033338 | 000 |
| 10603295008798 | K033338 | 000 |
| 10603295008781 | K033338 | 000 |
| 10603295008774 | K033338 | 000 |
| 10603295008767 | K033338 | 000 |
| 10603295008750 | K033338 | 000 |
| 10603295008743 | K033338 | 000 |
| 10603295008736 | K033338 | 000 |
| 10603295013426 | K033338 | 000 |
| 10603295008842 | K033338 | 000 |
| 10603295008859 | K033338 | 000 |
| 10603295009719 | K033338 | 000 |
| 10603295009702 | K033338 | 000 |
| 10603295008965 | K033338 | 000 |
| 10603295008958 | K033338 | 000 |
| 10603295008941 | K033338 | 000 |
| 10603295008934 | K033338 | 000 |
| 10603295008927 | K033338 | 000 |
| 10603295008910 | K033338 | 000 |
| 10603295008903 | K033338 | 000 |
| 10603295008880 | K033338 | 000 |
| 10603295008873 | K033338 | 000 |
| 10603295008866 | K033338 | 000 |
| 10603295013419 | K033338 | 000 |