The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Metal-on-metal Hip Systems-additional Contraindications.
| Device ID | K113271 |
| 510k Number | K113271 |
| Device Name: | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. P.O BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET MANUFACTURING, INC. 56 EAST BELL DR. P.O BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-05-18 |
| Summary: | summary |