The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Mc-subtalar(tm) Ii.
| Device ID | K160548 |
| 510k Number | K160548 |
| Device Name: | MC-Subtalar(TM) II |
| Classification | Screw, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH ALT-LANKWITZ Berlin, DE 12247 |
| Contact | Paul Munch |
| Correspondent | Matthias Mollmann MERETE TECHNOLOGIES INC ONE LINCOLN CENTER, 18W140 BUTTERFIELD ROAD Oakbrook Terrace, IL 60181 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266163042 | K160548 | 000 |
| 04048266163035 | K160548 | 000 |
| 04048266163028 | K160548 | 000 |
| 04048266163011 | K160548 | 000 |
| 04048266163004 | K160548 | 000 |
| 04048266162991 | K160548 | 000 |
| 04048266162984 | K160548 | 000 |
| 04048266162977 | K160548 | 000 |
| 04048266162960 | K160548 | 000 |