The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Pediatros Rigidtack/flextack.
| Device ID | K151762 |
| 510k Number | K151762 |
| Device Name: | PediatrOS RigidTack/FlexTack |
| Classification | Staple, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH ALT-LANKWITZ 102 Berlin, DE 12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Matthias Möllmann MERETE MEDICAL, INC. 4 CROTTY LANE, SUITE 118 NEW YORK INTERNATIONAL PLAZA New Windsor, NY 12553 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2015-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266150394 | K151762 | 000 |
| 04048266150387 | K151762 | 000 |
| 04048266147066 | K151762 | 000 |
| 04048266139580 | K151762 | 000 |
| 04048266138279 | K151762 | 000 |
| 04048266138163 | K151762 | 000 |