The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Sternal Closure System.
| Device ID | K121302 |
| 510k Number | K121302 |
| Device Name: | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Sheryl Malmberg |
| Correspondent | Sheryl Malmberg BIOMET MICROFIXATION 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 | 2012-05-01 |
| Decision Date | 2012-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036184476 | K121302 | 000 |
| 00841036169848 | K121302 | 000 |
| 00841036169763 | K121302 | 000 |
| 00841036168933 | K121302 | 000 |
| 00841036167707 | K121302 | 000 |
| 00841036167370 | K121302 | 000 |
| 00841036164034 | K121302 | 000 |
| 00841036162757 | K121302 | 000 |
| 00841036162740 | K121302 | 000 |
| 00841036159733 | K121302 | 000 |
| 00841036159726 | K121302 | 000 |
| 00841036156503 | K121302 | 000 |
| 00888233018074 | K121302 | 000 |
| 00888233017619 | K121302 | 000 |
| 00841036170080 | K121302 | 000 |
| 00841036170264 | K121302 | 000 |
| 00841036184469 | K121302 | 000 |
| 00841036183141 | K121302 | 000 |
| 00841036183134 | K121302 | 000 |
| 00841036179519 | K121302 | 000 |
| 00841036170257 | K121302 | 000 |
| 00841036203696 | K121302 | 000 |
| 00841036196059 | K121302 | 000 |
| 00841036187903 | K121302 | 000 |
| 00841036182502 | K121302 | 000 |
| 00841036177089 | K121302 | 000 |
| 00841036177072 | K121302 | 000 |
| 00841036175085 | K121302 | 000 |
| 00841036175078 | K121302 | 000 |
| 00888233017596 | K121302 | 000 |