The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Most Hex Intramedullary (i/m) Stem.
| Device ID | K973087 |
| 510k Number | K973087 |
| Device Name: | MOST HEX INTRAMEDULLARY (I/M) STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KRO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-14 |
| Summary: | summary |