The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Lactosorb Meniscal Screw.
| Device ID | K002020 |
| 510k Number | K002020 |
| Device Name: | LACTOSORB MENISCAL SCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET MANUFACTURING, INC. 56 EAST BELL DR. 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 | 2000-07-03 |
| Decision Date | 2000-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304421233 | K002020 | 000 |
| 00880304421226 | K002020 | 000 |