The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Juggerknot Soft Anchors.
| Device ID | K150768 |
| 510k Number | K150768 |
| Device Name: | JuggerKnot Soft Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304858961 | K150768 | 000 |
| 00880304700703 | K150768 | 000 |
| 00880304685550 | K150768 | 000 |
| 00880304685345 | K150768 | 000 |
| 00880304685338 | K150768 | 000 |
| 00880304685321 | K150768 | 000 |
| 00880304685314 | K150768 | 000 |
| 00880304685291 | K150768 | 000 |
| 00880304685284 | K150768 | 000 |
| 00889024581586 | K150768 | 000 |
| 00889024582910 | K150768 | 000 |
| 00880304700727 | K150768 | 000 |
| 00880304700741 | K150768 | 000 |
| 00880304700772 | K150768 | 000 |
| 00880304858954 | K150768 | 000 |
| 00880304731189 | K150768 | 000 |
| 00880304731141 | K150768 | 000 |
| 00880304709584 | K150768 | 000 |
| 00880304709553 | K150768 | 000 |
| 00880304705531 | K150768 | 000 |
| 00880304704534 | K150768 | 000 |
| 00880304701304 | K150768 | 000 |
| 00880304701229 | K150768 | 000 |
| 00880304701212 | K150768 | 000 |
| 00887868578397 | K150768 | 000 |