The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Revision Cup, Model 02-2yy-zzzz.
| Device ID | K001759 |
| 510k Number | K001759 |
| Device Name: | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ |
| 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 | 2000-06-09 |
| Decision Date | 2000-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024310940 | K001759 | 000 |
| 00889024310841 | K001759 | 000 |
| 00889024310858 | K001759 | 000 |
| 00889024310865 | K001759 | 000 |
| 00889024310872 | K001759 | 000 |
| 00889024310889 | K001759 | 000 |
| 00889024310896 | K001759 | 000 |
| 00889024310902 | K001759 | 000 |
| 00889024310919 | K001759 | 000 |
| 00889024310926 | K001759 | 000 |
| 00889024310933 | K001759 | 000 |
| 00889024310834 | K001759 | 000 |