The following data is part of a premarket notification filed by Biomet Microfixation, Inc. with the FDA for Biomet Microfixation Sternalock Blu Sternal Closure System.
| Device ID | K110574 |
| 510k Number | K110574 |
| Device Name: | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Sheryl Malmberg |
| Correspondent | Sheryl Malmberg BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-05-18 |
| Summary: | summary |