The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-hip System Porous Stem With Ha/csti.
| Device ID | K970300 |
| 510k Number | K970300 |
| Device Name: | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Lori Kleinschridt Holder |
| Correspondent | Lori Kleinschridt Holder INTERMEDICS ORTHOPEDICS 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 | 1997-01-24 |
| Decision Date | 1997-07-03 |
| Summary: | summary |