The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Panels And Fasteners.
| Device ID | K980927 |
| 510k Number | K980927 |
| Device Name: | LACTOSORB PANELS AND FASTENERS |
| 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 | 1998-03-11 |
| Decision Date | 1998-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036195328 | K980927 | 000 |
| 00841036055998 | K980927 | 000 |
| 00841036055974 | K980927 | 000 |
| 00841036055899 | K980927 | 000 |
| 00841036055875 | K980927 | 000 |
| 00888233025287 | K980927 | 000 |