The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Duothreadtm Bone Screw.
| Device ID | K050924 |
| 510k Number | K050924 |
| Device Name: | MERETE DUOTHREADTM BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Contact | Jenik Radon |
| Correspondent | Jenik Radon MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-13 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266024947 | K050924 | 000 |
| 04048266024817 | K050924 | 000 |
| 04048266024800 | K050924 | 000 |
| 04048266024794 | K050924 | 000 |
| 04048266024787 | K050924 | 000 |
| 04048266024770 | K050924 | 000 |
| 04048266024763 | K050924 | 000 |
| 04048266024756 | K050924 | 000 |
| 04048266024749 | K050924 | 000 |
| 04048266024732 | K050924 | 000 |
| 04048266024725 | K050924 | 000 |
| 04048266024824 | K050924 | 000 |
| 04048266024831 | K050924 | 000 |
| 04048266024930 | K050924 | 000 |
| 04048266024923 | K050924 | 000 |
| 04048266024916 | K050924 | 000 |
| 04048266024909 | K050924 | 000 |
| 04048266024893 | K050924 | 000 |
| 04048266024886 | K050924 | 000 |
| 04048266024879 | K050924 | 000 |
| 04048266024862 | K050924 | 000 |
| 04048266024855 | K050924 | 000 |
| 04048266024848 | K050924 | 000 |
| 04048266024718 | K050924 | 000 |