The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Compression Screws.
| Device ID | K091798 |
| 510k Number | K091798 |
| Device Name: | MERETE COMPRESSION SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Jorg Mietzner |
| Correspondent | Jorg Mietzner MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266053480 | K091798 | 000 |
| 04048266053596 | K091798 | 000 |
| 04048266053602 | K091798 | 000 |
| 04048266053619 | K091798 | 000 |
| 04048266053626 | K091798 | 000 |
| 04048266053633 | K091798 | 000 |
| 04048266053640 | K091798 | 000 |
| 04048266053657 | K091798 | 000 |
| 04048266053664 | K091798 | 000 |
| 04048266053589 | K091798 | 000 |
| 04048266053572 | K091798 | 000 |
| 04048266053565 | K091798 | 000 |
| 04048266053473 | K091798 | 000 |
| 04048266053497 | K091798 | 000 |
| 04048266053503 | K091798 | 000 |
| 04048266053510 | K091798 | 000 |
| 04048266053527 | K091798 | 000 |
| 04048266053534 | K091798 | 000 |
| 04048266053541 | K091798 | 000 |
| 04048266053558 | K091798 | 000 |
| 04048266053671 | K091798 | 000 |
| 04048266053688 | K091798 | 000 |
| 04048266053695 | K091798 | 000 |
| 04048266053824 | K091798 | 000 |
| 04048266053831 | K091798 | 000 |
| 04048266053848 | K091798 | 000 |
| 04048266053855 | K091798 | 000 |
| 04048266053879 | K091798 | 000 |
| 04048266053909 | K091798 | 000 |
| 04048266053923 | K091798 | 000 |
| 04048266053930 | K091798 | 000 |
| 04048266053817 | K091798 | 000 |
| 04048266053800 | K091798 | 000 |
| 04048266053794 | K091798 | 000 |
| 04048266053701 | K091798 | 000 |
| 04048266053718 | K091798 | 000 |
| 04048266053725 | K091798 | 000 |
| 04048266053732 | K091798 | 000 |
| 04048266053749 | K091798 | 000 |
| 04048266053756 | K091798 | 000 |
| 04048266053763 | K091798 | 000 |
| 04048266053770 | K091798 | 000 |
| 04048266053947 | K091798 | 000 |