The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Vision Footring System.
| Device ID | K071395 |
| 510k Number | K071395 |
| Device Name: | BIOMET VISION FOOTRING SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Robert Friddle |
| Correspondent | Robert Friddle BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304532205 | K071395 | 000 |
| 00888480222040 | K071395 | 000 |
| 00888480222026 | K071395 | 000 |
| 00888480221524 | K071395 | 000 |
| 00888480221487 | K071395 | 000 |
| 00888480221463 | K071395 | 000 |
| 00888480221449 | K071395 | 000 |
| 00888480221388 | K071395 | 000 |
| 00888480221371 | K071395 | 000 |
| 00888480221364 | K071395 | 000 |
| 00888480221296 | K071395 | 000 |
| 00888480222088 | K071395 | 000 |
| 00888480222224 | K071395 | 000 |
| 00880304498150 | K071395 | 000 |
| 00880304282780 | K071395 | 000 |
| 00887868106262 | K071395 | 000 |
| 00887868106255 | K071395 | 000 |
| 00887868106248 | K071395 | 000 |
| 00887868106231 | K071395 | 000 |
| 00887868097652 | K071395 | 000 |
| 00888480222569 | K071395 | 000 |
| 00888480222507 | K071395 | 000 |
| 00888480222309 | K071395 | 000 |
| 00880304495210 | K071395 | 000 |