The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Foot Plates And Screws.
| Device ID | K151235 |
| 510k Number | K151235 |
| Device Name: | Medline Foot Plates And Screws |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2015-08-06 |
| Summary: | summary |