The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Trabecular Metal Monoblock Cup, Models 00-7259-0xx-28 (zimmer Cat. #) And 02-293-28xx1 (implex Part #).
| Device ID | K021970 |
| 510k Number | K021970 |
| Device Name: | THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-17 |
| Decision Date | 2002-07-12 |
| Summary: | summary |