The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Cannulated Compression Screws, Aptus Headed Cannulated Compression Screws, Aptus K-wire System.
Device ID | K202589 |
510k Number | K202589 |
Device Name: | APTUS Cannulated Compression Screws, APTUS Headed Cannulated Compression Screws, APTUS K-Wire System |
Classification | Screw, Fixation, Bone |
Applicant | Medartis AG Hochbergerstrasse 60E Basel, CH Ch-4057 |
Contact | Andrea Kiefer-schweizer |
Correspondent | Lauren M. Wessell PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | HWC |
Subsequent Product Code | HTN |
Subsequent Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-08 |
Decision Date | 2020-11-06 |