The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Hammerloc Tm Tibial Fixation Device.
| Device ID | K103145 |
| 510k Number | K103145 |
| Device Name: | HAMMERLOC TM TIBIAL FIXATION DEVICE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Robert Friddle |
| Correspondent | Robert Friddle BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304516779 | K103145 | 000 |
| 00880304516755 | K103145 | 000 |
| 00880304516748 | K103145 | 000 |
| 00880304516687 | K103145 | 000 |
| 00887868226670 | K103145 | 000 |
| 00887868226663 | K103145 | 000 |
| 00887868226656 | K103145 | 000 |
| 00887868226649 | K103145 | 000 |