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 |