The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Lateral Troch Plate.
| Device ID | K003294 |
| 510k Number | K003294 |
| Device Name: | BIOMET LATERAL TROCH PLATE |
| Classification | Pin, Fixation, Threaded |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2000-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304360730 | K003294 | 000 |
| 00880304360716 | K003294 | 000 |
| 00880304360709 | K003294 | 000 |