The following data is part of a premarket notification filed by Implex Corp. with the FDA for Proxilock Hip Prosthesis; Size 12/36.
| Device ID | K022966 |
| 510k Number | K022966 |
| Device Name: | PROXILOCK HIP PROSTHESIS; SIZE 12/36 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2002-10-02 |
| Summary: | summary |