The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Biocomposite Suture Anchor With Disposable Driver.
Device ID | K170501 |
510k Number | K170501 |
Device Name: | CrossFT Knotless Biocomposite Suture Anchor With Disposable Driver |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
Contact | Diana L. Nader-martone |
Correspondent | Diana L. Nader-martone ConMed Corporation 525 French Road Utica, NY 13502 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-21 |
Decision Date | 2017-03-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854045791 | K170501 | 000 |
10845854045787 | K170501 | 000 |
10845854045817 | K170501 | 000 |
10845854045824 | K170501 | 000 |
10845854045831 | K170501 | 000 |
10845854045848 | K170501 | 000 |
10845854045855 | K170501 | 000 |
10845854045862 | K170501 | 000 |
10845854045800 | K170501 | 000 |
30845854045798 | K170501 | 000 |