The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Alloclassic Zweymueller Sl/sll Femoral Stem.
| Device ID | K030373 |
| 510k Number | K030373 |
| Device Name: | ALLOCLASSIC ZWEYMUELLER SL/SLL 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 | Audrey Swearingen |
| Correspondent | Audrey Swearingen 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 | 2003-02-04 |
| Decision Date | 2003-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024298187 | K030373 | 000 |
| 00889024298309 | K030373 | 000 |
| 00889024298316 | K030373 | 000 |
| 00889024431409 | K030373 | 000 |
| 00889024431416 | K030373 | 000 |
| 00889024431423 | K030373 | 000 |
| 00889024431430 | K030373 | 000 |
| 00889024431447 | K030373 | 000 |
| 00889024431454 | K030373 | 000 |
| 00889024298293 | K030373 | 000 |
| 00889024298286 | K030373 | 000 |
| 00889024298279 | K030373 | 000 |
| 00889024298194 | K030373 | 000 |
| 00889024298200 | K030373 | 000 |
| 00889024298217 | K030373 | 000 |
| 00889024298224 | K030373 | 000 |
| 00889024298231 | K030373 | 000 |
| 00889024298248 | K030373 | 000 |
| 00889024298255 | K030373 | 000 |
| 00889024298262 | K030373 | 000 |
| 00889024431461 | K030373 | 000 |
| 00889024431478 | K030373 | 000 |
| 00889024465572 | K030373 | 000 |
| 00889024465589 | K030373 | 000 |
| 00889024465596 | K030373 | 000 |
| 00889024465602 | K030373 | 000 |
| 00889024465619 | K030373 | 000 |
| 00889024465626 | K030373 | 000 |
| 00889024465633 | K030373 | 000 |
| 00889024465640 | K030373 | 000 |
| 00889024465565 | K030373 | 000 |
| 00889024465558 | K030373 | 000 |
| 00889024465541 | K030373 | 000 |
| 00889024431485 | K030373 | 000 |
| 00889024431492 | K030373 | 000 |
| 00889024431508 | K030373 | 000 |
| 00889024431515 | K030373 | 000 |
| 00889024431522 | K030373 | 000 |
| 00889024431539 | K030373 | 000 |
| 00889024465527 | K030373 | 000 |
| 00889024465534 | K030373 | 000 |
| 00889024465657 | K030373 | 000 |