The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Meniscal Repair Device.
| Device ID | K982095 |
| 510k Number | K982095 |
| Device Name: | LACTOSORB MENISCAL REPAIR DEVICE |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1999-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304007314 | K982095 | 000 |
| 00880304007253 | K982095 | 000 |