The following data is part of a premarket notification filed by Merete Gmbh with the FDA for Mecron Cannulated Screw System.
Device ID | K172213 |
510k Number | K172213 |
Device Name: | MECRON Cannulated Screw System |
Classification | Screw, Fixation, Bone |
Applicant | Merete GmbH Alt-Lankwitz 102 Berlin, DE 12247 |
Contact | Paul Munch |
Correspondent | Paul Munch Merete GmbH Alt-Lankwitz 102 Berlin, DE 12247 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-24 |
Decision Date | 2017-10-23 |
Summary: | summary |