The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Osteo-cable Sleeve.
| Device ID | K024022 |
| 510k Number | K024022 |
| Device Name: | OSTEO-CABLE SLEEVE |
| Classification | Applier, Cerclage |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | HXN |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-05 |
| Decision Date | 2003-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304360556 | K024022 | 000 |
| 00880304002708 | K024022 | 000 |