The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Mod. Femoral Comp. Non-beaded & Basic Ace. Shell.
| Device ID | K894148 |
| 510k Number | K894148 |
| Device Name: | MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert Smith |
| Correspondent | Robert Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1989-09-05 |