The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Cable-ease Plate And Cable System - Trochanteric Hook.
Device ID | K950027 |
510k Number | K950027 |
Device Name: | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK |
Classification | Cerclage, Fixation |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Barry J Hassett |
Correspondent | Barry J Hassett INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-04 |
Decision Date | 1995-03-06 |