The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modified Bmp Trochanteric Plates.
| Device ID | K993510 |
| 510k Number | K993510 |
| Device Name: | MODIFIED BMP TROCHANTERIC PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Fred Mcclure |
| Correspondent | Fred Mcclure BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 1999-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304360792 | K993510 | 000 |
| 00880304360785 | K993510 | 000 |
| 00880304360778 | K993510 | 000 |
| 00880304360761 | K993510 | 000 |
| 00880304360754 | K993510 | 000 |
| 00880304360747 | K993510 | 000 |