The following data is part of a premarket notification filed by Biomet Sports Medicine, Inc. with the FDA for Sleeve And Button Soft Tissue Devices.
| Device ID | K071704 |
| 510k Number | K071704 |
| Device Name: | SLEEVE AND BUTTON SOFT TISSUE DEVICES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET SPORTS MEDICINE, INC. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET SPORTS MEDICINE, INC. 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 | 2007-06-21 |
| Decision Date | 2007-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304610637 | K071704 | 000 |
| 00887868489396 | K071704 | 000 |
| 00887868489402 | K071704 | 000 |
| 00887868489419 | K071704 | 000 |
| 00887868489426 | K071704 | 000 |
| 00887868489433 | K071704 | 000 |
| 00880304477209 | K071704 | 000 |
| 00880304477315 | K071704 | 000 |
| 00880304516557 | K071704 | 000 |
| 00880304539211 | K071704 | 000 |
| 00880304541191 | K071704 | 000 |
| 00880304541207 | K071704 | 000 |
| 00880304541214 | K071704 | 000 |
| 00880304541221 | K071704 | 000 |
| 00880304610620 | K071704 | 000 |
| 00887868489389 | K071704 | 000 |