The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Continuum Patella-revision Hedrocel Patella.
| Device ID | K983835 |
| 510k Number | K983835 |
| Device Name: | IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert Poggie |
| Correspondent | Robert Poggie 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 | 1998-10-30 |
| Decision Date | 1999-03-15 |
| Summary: | summary |