The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Hydroxyapatite Infinity Trochanteric Module.
Device ID | K915350 |
510k Number | K915350 |
Device Name: | HYDROXYAPATITE INFINITY TROCHANTERIC MODULE |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Kim Tompkins |
Correspondent | Kim Tompkins DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-26 |
Decision Date | 1992-02-03 |