The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Nexus(tm) Femoral Hip Stem.
Device ID | K911052 |
510k Number | K911052 |
Device Name: | NEXUS(TM) FEMORAL HIP STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
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 | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-08 |
Decision Date | 1991-06-17 |