The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for G7 Acetabular System.
| Device ID | K121874 |
| 510k Number | K121874 |
| Device Name: | G7 ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | PBI |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-27 |
| Decision Date | 2012-11-23 |
| Summary: | summary |