The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 System.
| Device ID | K981560 |
| 510k Number | K981560 |
| Device Name: | IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John A Schalago |
| Correspondent | John A Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-01 |
| Decision Date | 1998-06-08 |
| Summary: | summary |