The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Agc V2 Revision Knee System.
| Device ID | K984054 |
| 510k Number | K984054 |
| Device Name: | AGC V2 REVISION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Beres |
| Correspondent | Patricia Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05019279387854 | K984054 | 000 |
| 05019279387830 | K984054 | 000 |
| 05019279387816 | K984054 | 000 |
| 05019279387793 | K984054 | 000 |
| 05019279387786 | K984054 | 000 |
| 05019279387779 | K984054 | 000 |
| 05019279387748 | K984054 | 000 |
| 05019279387700 | K984054 | 000 |