The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-xxyyy, 02-247-xxyyy, 02-248-xxyyy.
| Device ID | K983128 |
| 510k Number | K983128 |
| Device Name: | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-12-03 |
| Summary: | summary |