The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Metafix Blp Plate, Size 31, Left, Metafix Blp Plate, Size 31,right.
| Device ID | K132226 |
| 510k Number | K132226 |
| Device Name: | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT |
| Classification | Plate, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-17 |
| Decision Date | 2013-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841742121864 | K132226 | 000 |
| 00841742121826 | K132226 | 000 |
| 04048266136404 | K132226 | 000 |
| 04048266136398 | K132226 | 000 |