The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Cls Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, Sl.
| Device ID | K973837 |
| 510k Number | K973837 |
| Device Name: | CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Shavawn Evans Parduhn |
| Correspondent | Shavawn Evans Parduhn SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1998-01-06 |
| Summary: | summary |