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 |