The following data is part of a premarket notification filed by Zimmer Austin, Inc. with the FDA for Cls Spotorno Stem.
| Device ID | K042249 |
| 510k Number | K042249 |
| Device Name: | CLS SPOTORNO STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER AUSTIN, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen ZIMMER AUSTIN, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-19 |
| Decision Date | 2004-09-15 |
| Summary: | summary |