The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Micromax Suture Anchor.
| Device ID | K040475 |
| 510k Number | K040475 |
| Device Name: | MICROMAX SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-24 |
| Decision Date | 2004-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304484948 | K040475 | 000 |
| 00880304420878 | K040475 | 000 |