The following data is part of a premarket notification filed by Nexmed, Inc. with the FDA for Nexflex Total Hip System.
| Device ID | K952629 |
| 510k Number | K952629 |
| Device Name: | NEXFLEX TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Bradford D Davis |
| Correspondent | Bradford D Davis NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-08 |
| Decision Date | 1995-09-08 |