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 |