The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Distally Fixed Hip Stem.
| Device ID | K971523 |
| 510k Number | K971523 |
| Device Name: | DISTALLY FIXED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Sam Mirza |
| Correspondent | Sam Mirza SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-10-01 |
| Summary: | summary |