The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Sternalock 360 Sternal Closure System.
| Device ID | K163007 |
| 510k Number | K163007 |
| Device Name: | Biomet Microfixation SternaLock 360 Sternal Closure System |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DRIVE Jacksonville, FL 32218 |
| Contact | Lauren Jasper |
| Correspondent | Lauren Jasper BIOMET MICROFIXATION 1520 TRADEPORT DRIVE 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 | 2016-10-28 |
| Decision Date | 2016-11-23 |
| Summary: | summary |