The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Natural-hip Porous Stem With Offset.
| Device ID | K973675 |
| 510k Number | K973675 |
| Device Name: | NATURAL-HIP POROUS STEM WITH OFFSET |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1997-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024178786 | K973675 | 000 |
| 00889024178779 | K973675 | 000 |
| 00889024178762 | K973675 | 000 |
| 00889024178755 | K973675 | 000 |
| 00889024178748 | K973675 | 000 |
| 00889024178731 | K973675 | 000 |