The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Expressbraid Graft Manipulation.
| Device ID | K152868 |
| 510k Number | K152868 |
| Device Name: | ExpressBraid Graft Manipulation |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IL 46581 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IL 46581 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304566712 | K152868 | 000 |
| 00880304566705 | K152868 | 000 |
| 00880304566675 | K152868 | 000 |
| 00880304566668 | K152868 | 000 |
| 70887868462565 | K152868 | 000 |
| 00887868462689 | K152868 | 000 |
| 00887868462672 | K152868 | 000 |
| 70887868462558 | K152868 | 000 |