The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Nexflex Total Hip System.
| Device ID | K042252 |
| 510k Number | K042252 |
| Device Name: | NEXFLEX TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Ellen A Yarnall |
| Correspondent | Ellen A Yarnall ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-20 |
| Decision Date | 2004-12-06 |
| Summary: | summary |