The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cruciate Ligament Button.
| Device ID | K813581 |
| 510k Number | K813581 |
| Device Name: | CRUCIATE LIGAMENT BUTTON |
| Classification | Retention Device, Suture |
| Applicant | BIOMET, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-28 |
| Decision Date | 1982-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304405387 | K813581 | 000 |
| 00880304405363 | K813581 | 000 |