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 |