The following data is part of a premarket notification filed by Biomet Microfixation, Inc. with the FDA for Biomet Microfixation Sternal Closure System.
| Device ID | K111908 |
| 510k Number | K111908 |
| Device Name: | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Kim Reed |
| Correspondent | Kim Reed BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036157272 | K111908 | 000 |
| 00841036150891 | K111908 | 000 |
| 00841036150006 | K111908 | 000 |
| 00841036148171 | K111908 | 000 |
| 00841036143978 | K111908 | 000 |
| 00888233011143 | K111908 | 000 |
| 00888233011082 | K111908 | 000 |
| 00888233011075 | K111908 | 000 |
| 00888233011037 | K111908 | 000 |