The following data is part of a premarket notification filed by Implex Corp. with the FDA for Cobrex Hip Stem, Model 01-128-xxxxx.
| Device ID | K991869 |
| 510k Number | K991869 |
| Device Name: | COBREX HIP STEM, MODEL 01-128-XXXXX |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-07-14 |
| Summary: | summary |