The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Resorbable No Profile Screw And Washer.
| Device ID | K012469 |
| 510k Number | K012469 |
| Device Name: | RESORBABLE NO PROFILE SCREW AND WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET MANUFACTURING, 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 | 2001-08-02 |
| Decision Date | 2001-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304420793 | K012469 | 000 |