The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Arthrotek Maxfire Meniscal Repair Device.
| Device ID | K061776 |
| 510k Number | K061776 |
| Device Name: | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-23 |
| Decision Date | 2006-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304475922 | K061776 | 000 |
| 00880304475915 | K061776 | 000 |
| 00880304460454 | K061776 | 000 |