The following data is part of a premarket notification filed by Implex Corp. with the FDA for Continuum Knee System-ps Femoral Components- Porous, Model Xx-yyy-zzzzz.
| Device ID | K001307 |
| 510k Number | K001307 |
| Device Name: | CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-24 |
| Decision Date | 2000-05-23 |