The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for No-profile Screws No-profile Washer No-profile Screws Washerloc Washers.
| Device ID | K122437 |
| 510k Number | K122437 |
| Device Name: | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2013-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304410145 | K122437 | 000 |
| 00887868568497 | K122437 | 000 |
| 00887868568503 | K122437 | 000 |
| 00887868568510 | K122437 | 000 |
| 00887868568527 | K122437 | 000 |
| 00880304405776 | K122437 | 000 |
| 00880304410060 | K122437 | 000 |
| 00880304410237 | K122437 | 000 |
| 00880304410244 | K122437 | 000 |
| 00880304409989 | K122437 | 000 |
| 00880304409996 | K122437 | 000 |
| 00880304410053 | K122437 | 000 |
| 00880304410114 | K122437 | 000 |
| 00887868568480 | K122437 | 000 |