The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Impact Co-cr 1-piece Femoral Component.
| Device ID | K942027 |
| 510k Number | K942027 |
| Device Name: | IMPACT CO-CR 1-PIECE FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Beres |
| Correspondent | Patricia Beres BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1994-09-19 |