The following data is part of a premarket notification filed by Implex Corp. with the FDA for Cross Linked Polyethylene Acetabular Components,model Xx-yy-zzzzzz.
| Device ID | K990330 |
| 510k Number | K990330 |
| Device Name: | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-02 |
| Decision Date | 2000-03-01 |
| Summary: | summary |