The following data is part of a premarket notification filed by Ebi,llc D/b/a Biomet Trauma with the FDA for Biodrive Micro Screw System.
| Device ID | K092670 |
| 510k Number | K092670 |
| Device Name: | BIODRIVE MICRO SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | EBI,LLC D/B/A BIOMET TRAUMA 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Shikha Gola |
| Correspondent | Shikha Gola EBI,LLC D/B/A BIOMET TRAUMA 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 | 2009-08-31 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888480429418 | K092670 | 000 |