The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Ribfix Blu Thoracic Fixation System.
| Device ID | K152253 |
| 510k Number | K152253 |
| Device Name: | Biomet Microfixation RibFix Blu Thoracic Fixation 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2016-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036219055 | K152253 | 000 |