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 |