The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Continuum Knee - Hedrocel Tibial Spacers.
| Device ID | K982302 |
| 510k Number | K982302 |
| Device Name: | IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John S Schalago |
| Correspondent | John S Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-07-31 |
| Summary: | summary |