The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Deep Thread Suture Anchor With Disposable Driver.
Device ID | K182621 |
510k Number | K182621 |
Device Name: | CrossFT Knotless Deep Thread Suture Anchor With Disposable Driver |
Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-24 |
Decision Date | 2019-01-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10845854606315 | K182621 | 000 |
10845854606230 | K182621 | 000 |