The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reunite Fusion Screw.
| Device ID | K011451 |
| 510k Number | K011451 |
| Device Name: | REUNITE FUSION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara Bailey Shultz |
| Correspondent | Sara Bailey Shultz BIOMET, INC. 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 | 2001-05-11 |
| Decision Date | 2001-12-10 |
| Summary: | summary |