The following data is part of a premarket notification filed by Biomet Orthopedics Corp. with the FDA for Mak Oss Femoral Knee Components.
| Device ID | K131393 |
| 510k Number | K131393 |
| Device Name: | MAK OSS FEMORAL KNEE COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET ORTHOPEDICS CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET ORTHOPEDICS CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304568433 | K131393 | 000 |
| 00880304658370 | K131393 | 000 |
| 00880304658363 | K131393 | 000 |
| 00887868463303 | K131393 | 000 |
| 00887868519437 | K131393 | 000 |
| 00887868519420 | K131393 | 000 |