The following data is part of a premarket notification filed by Biomet Manufacturing Llc with the FDA for Biomet Side Access Distal Femoral Expandable.
| Device ID | K140509 |
| 510k Number | K140509 |
| Device Name: | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING LLC 56 EAST BELL DR. Warsaw, IN 46581 |
| Contact | Tracy Bickel Johnson, Rac |
| Correspondent | Tracy Bickel Johnson, Rac BIOMET MANUFACTURING LLC 56 EAST BELL DR. Warsaw, IN 46581 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304928527 | K140509 | 000 |
| 00880304703322 | K140509 | 000 |
| 00880304703315 | K140509 | 000 |
| 00880304703308 | K140509 | 000 |
| 00880304703292 | K140509 | 000 |
| 00880304703285 | K140509 | 000 |
| 00880304703278 | K140509 | 000 |
| 00880304654426 | K140509 | 000 |
| 00880304654419 | K140509 | 000 |
| 00880304548404 | K140509 | 000 |
| 00880304703339 | K140509 | 000 |
| 00880304703346 | K140509 | 000 |
| 00880304703353 | K140509 | 000 |
| 00880304927476 | K140509 | 000 |
| 00880304703438 | K140509 | 000 |
| 00880304703421 | K140509 | 000 |
| 00880304703414 | K140509 | 000 |
| 00880304703407 | K140509 | 000 |
| 00880304703391 | K140509 | 000 |
| 00880304703384 | K140509 | 000 |
| 00880304703377 | K140509 | 000 |
| 00880304703360 | K140509 | 000 |
| 00887868552779 | K140509 | 000 |