The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Suture Anchor With Disposable Driver.
Device ID | K163258 |
510k Number | K163258 |
Device Name: | CrossFT Knotless Suture Anchor With Disposable Driver |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
Contact | Nyrobia Freeman |
Correspondent | Nyrobia Freeman ConMed Corporation 525 French Road Utica, NY 13502 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-21 |
Decision Date | 2017-01-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854649838 | K163258 | 000 |
20845854649821 | K163258 | 000 |
10845854044599 | K163258 | 000 |