The following data is part of a premarket notification filed by Nexmed, Inc. with the FDA for Nexlock Femoral Stem.
Device ID | K955171 |
510k Number | K955171 |
Device Name: | NEXLOCK FEMORAL STEM |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Contact | Rebecca H Wahl |
Correspondent | Rebecca H Wahl NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-13 |
Decision Date | 1996-02-09 |