The following data is part of a premarket notification filed by Biomet Trauma (aka Ebi, Lp) with the FDA for Smple Plate And Screws.
| Device ID | K093983 |
| 510k Number | K093983 |
| Device Name: | SMPLE PLATE AND SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET TRAUMA (AKA EBI, LP) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe BIOMET TRAUMA (AKA EBI, LP) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-03-19 |
| Summary: | summary |