The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Biomet Sports Medicine Sternal Closure System.
| Device ID | K110039 |
| 510k Number | K110039 |
| Device Name: | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-06 |
| Decision Date | 2011-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304360815 | K110039 | 000 |