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 | K171592 |
510k Number | K171592 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-31 |
Decision Date | 2017-08-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CROSSFT 86920366 5157718 Live/Registered |
Conmed Corporation 2016-02-25 |
CROSSFT 77720451 not registered Dead/Abandoned |
LINVATEC CORPORATION 2009-04-23 |