The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-hip System - Calcar Replacement Hip Stem.
Device ID | K961727 |
510k Number | K961727 |
Device Name: | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Sam Mirza |
Correspondent | Sam Mirza INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-03 |
Decision Date | 1996-07-19 |
Summary: | summary |