The following data is part of a premarket notification filed by Nexmed, Inc. with the FDA for Nexflex Femoral Stem, Standard Design.
| Device ID | K955170 |
| 510k Number | K955170 |
| Device Name: | NEXFLEX FEMORAL STEM, STANDARD DESIGN |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-02-09 |