The following data is part of a premarket notification filed by Biomet Trauma with the FDA for Optilock Periarticular Plating.
| Device ID | K092078 |
| 510k Number | K092078 |
| Device Name: | OPTILOCK PERIARTICULAR PLATING |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET TRAUMA 100 INTERFACE PARKWAY Parsippany, NJ 07054 |
| Contact | Shikha Gola |
| Correspondent | Shikha Gola BIOMET TRAUMA 100 INTERFACE PARKWAY Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2009-08-05 |
| Summary: | summary |