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 |