The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Inc. Natural-hip System Ld Stem.
| Device ID | K001320 |
| 510k Number | K001320 |
| Device Name: | SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-07-07 |