The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Pop Rivet.
| Device ID | K981798 |
| 510k Number | K981798 |
| Device Name: | LACTOSORB POP RIVET |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Julie K Ryan |
| Correspondent | Julie K Ryan BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDR |
| Subsequent Product Code | HRX |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-07-13 |
| Summary: | summary |