The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cannulated Arthrorivet And Cannulated Rc Arthrorivet.
| Device ID | K033519 |
| 510k Number | K033519 |
| Device Name: | CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-07 |
| Decision Date | 2003-12-05 |
| Summary: | summary |