The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Locking Bone Plate System Ii.
| Device ID | K102688 |
| 510k Number | K102688 |
| Device Name: | MERETE LOCKING BONE PLATE SYSTEM II |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis 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 | 2010-09-17 |
| Decision Date | 2010-12-03 |
| Summary: | summary |