The following data is part of a premarket notification filed by Nexmed, Inc. with the FDA for Nexflex Total Knee System.
| Device ID | K991882 |
| 510k Number | K991882 |
| Device Name: | NEXFLEX TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | NEXMED, INC. 42-160 STATE ST., SUITE B Palm Desert, CA 92211 |
| Contact | Jason Blain |
| Correspondent | Jason Blain NEXMED, INC. 42-160 STATE ST., SUITE B Palm Desert, CA 92211 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 1999-12-08 |
| Summary: | summary |