The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for G7 Dual Mobility System.
| Device ID | K150522 |
| 510k Number | K150522 |
| Device Name: | G7 Dual Mobility System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Amy Walriven |
| Correspondent | Amy Walriven BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304703568 | K150522 | 000 |
| 05019279999361 | K150522 | 000 |
| 05019279998258 | K150522 | 000 |
| 05019279998241 | K150522 | 000 |
| 05019279998234 | K150522 | 000 |
| 05019279998227 | K150522 | 000 |
| 05019279998210 | K150522 | 000 |
| 00880304712928 | K150522 | 000 |
| 00880304712911 | K150522 | 000 |
| 00880304712904 | K150522 | 000 |
| 00880304712898 | K150522 | 000 |
| 00880304712881 | K150522 | 000 |
| 00880304712874 | K150522 | 000 |
| 00880304712867 | K150522 | 000 |
| 00880304712850 | K150522 | 000 |
| 00880304712843 | K150522 | 000 |
| 05019279999378 | K150522 | 000 |
| 05019279999385 | K150522 | 000 |
| 00880304703544 | K150522 | 000 |
| 00880304703537 | K150522 | 000 |
| 00880304527416 | K150522 | 000 |
| 00880304527409 | K150522 | 000 |
| 00880304703520 | K150522 | 000 |
| 00880304734951 | K150522 | 000 |
| 00880304734944 | K150522 | 000 |
| 00880304703513 | K150522 | 000 |
| 00880304703506 | K150522 | 000 |
| 00880304703490 | K150522 | 000 |
| 00880304703483 | K150522 | 000 |
| 00880304691049 | K150522 | 000 |
| 00880304703551 | K150522 | 000 |
| 05019279999408 | K150522 | 000 |
| 05019279999392 | K150522 | 000 |
| 00880304712829 | K150522 | 000 |