The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Orthosorb Ls.
| Device ID | K140625 |
| 510k Number | K140625 |
| Device Name: | ORTHOSORB LS |
| Classification | Pin, Fixation, Resorbable, Hard Tissue |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Victoria Scheitlin |
| Correspondent | Victoria Scheitlin BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | OVZ |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-11 |
| Decision Date | 2014-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868130830 | K140625 | 000 |
| 00887868130823 | K140625 | 000 |
| 00887868130816 | K140625 | 000 |
| 00887868130809 | K140625 | 000 |
| 00887868130793 | K140625 | 000 |