The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-hip(tm) System - Calcar Replcement Stem.
Device ID | K945516 |
510k Number | K945516 |
Device Name: | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Joann Ringer-kuhne |
Correspondent | Joann Ringer-kuhne INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-09 |
Decision Date | 1995-02-14 |