The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Modification To Alloclassic Zweymuller Sl Offset Femoral Stem.
| Device ID | K033664 |
| 510k Number | K033664 |
| Device Name: | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2003-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024431119 | K033664 | 000 |
| 00889024278141 | K033664 | 000 |
| 00889024278134 | K033664 | 000 |
| 00889024278127 | K033664 | 000 |
| 00889024278110 | K033664 | 000 |
| 00889024278103 | K033664 | 000 |
| 00889024278097 | K033664 | 000 |
| 00889024278080 | K033664 | 000 |
| 00889024278073 | K033664 | 000 |
| 00889024278066 | K033664 | 000 |
| 00889024278059 | K033664 | 000 |
| 00889024278042 | K033664 | 000 |
| 00889024278035 | K033664 | 000 |
| 00889024278158 | K033664 | 000 |
| 00889024430983 | K033664 | 000 |
| 00889024431102 | K033664 | 000 |
| 00889024431096 | K033664 | 000 |
| 00889024431089 | K033664 | 000 |
| 00889024431072 | K033664 | 000 |
| 00889024431065 | K033664 | 000 |
| 00889024431058 | K033664 | 000 |
| 00889024431041 | K033664 | 000 |
| 00889024431034 | K033664 | 000 |
| 00889024431027 | K033664 | 000 |
| 00889024431010 | K033664 | 000 |
| 00889024431003 | K033664 | 000 |
| 00889024430990 | K033664 | 000 |
| H8440100121000 | K033664 | 000 |