The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Infinity(tm) Porous-coated Trochanteric Module.
Device ID | K911595 |
510k Number | K911595 |
Device Name: | INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Micki Roy |
Correspondent | Micki Roy DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-09 |
Decision Date | 1991-07-12 |