The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Blp Small Fragment Locking Bone Plate.
| Device ID | K063487 |
| 510k Number | K063487 |
| Device Name: | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Donna Coleman |
| Correspondent | Donna Coleman MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841742121895 | K063487 | 000 |
| 04048266024534 | K063487 | 000 |
| 04048266024503 | K063487 | 000 |
| 04048266024497 | K063487 | 000 |
| 04048266040053 | K063487 | 000 |
| 04048266024596 | K063487 | 000 |
| 04048266024589 | K063487 | 000 |
| 04048266024541 | K063487 | 000 |
| 04048266024527 | K063487 | 000 |
| 04048266024510 | K063487 | 000 |
| 04048266024558 | K063487 | 000 |
| 04048266024565 | K063487 | 000 |
| 04048266036865 | K063487 | 000 |
| 00841742121888 | K063487 | 000 |
| 00841742121871 | K063487 | 000 |
| 00841742121857 | K063487 | 000 |
| 00841742121840 | K063487 | 000 |
| 00841742121833 | K063487 | 000 |
| 04048266040077 | K063487 | 000 |
| 04048266040046 | K063487 | 000 |
| 04048266040039 | K063487 | 000 |
| 04048266040022 | K063487 | 000 |
| 04048266024572 | K063487 | 000 |