The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 20-hole Adaptation Plate.
Device ID | K981070 |
510k Number | K981070 |
Device Name: | 20-HOLE ADAPTATION PLATE |
Classification | Plate, Bone |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Mary Verstynen |
Correspondent | Mary Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-24 |
Decision Date | 1998-05-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841036195229 | K981070 | 000 |
00841036055691 | K981070 | 000 |
00888233025393 | K981070 | 000 |