The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Hep Acetabular Cup System, Cemented.
| Device ID | K971705 |
| 510k Number | K971705 |
| Device Name: | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Contact | Glenn N Byrd |
| Correspondent | Glenn N Byrd IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-08 |
| Decision Date | 1997-08-06 |
| Summary: | summary |