The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osteobridge Idsf - Intramedullary Diaphyseal Segmental Defect Fixation Rod System.
| Device ID | K142451 |
| 510k Number | K142451 |
| Device Name: | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MERETE MEDICAL GMBH ALT-LANKWITZ 102 Berlin, DE 12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Rudiger Hilken MERETE MEDICAL, INC. 4 CROTTY LANE- SUITE 118, NEW YORK INTERNATIONAL PLAZA New Windsor, NY 12553 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266147394 | K142451 | 000 |
| 04048266140623 | K142451 | 000 |
| 04048266140630 | K142451 | 000 |
| 04048266140647 | K142451 | 000 |
| 04048266140654 | K142451 | 000 |
| 04048266140678 | K142451 | 000 |
| 04048266140685 | K142451 | 000 |
| 04048266140692 | K142451 | 000 |
| 04048266147356 | K142451 | 000 |
| 04048266147363 | K142451 | 000 |
| 04048266147370 | K142451 | 000 |
| 04048266140616 | K142451 | 000 |