The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Continuum Hip System Acetabular Components - Model Xx-yyy-zzzz.
| Device ID | K003181 |
| 510k Number | K003181 |
| Device Name: | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John Schalago |
| Correspondent | John Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-11 |
| Decision Date | 2000-11-07 |