The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Bipolar Hip System.
| Device ID | K970447 |
| 510k Number | K970447 |
| Device Name: | IMPLEX BIPOLAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | James E Malayter |
| Correspondent | James E Malayter IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-04-30 |