The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated Pcs 3.0.
| Device ID | K140069 |
| 510k Number | K140069 |
| Device Name: | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841742122397 | K140069 | 000 |
| 04048266139146 | K140069 | 000 |
| 04048266139153 | K140069 | 000 |
| 04048266139160 | K140069 | 000 |
| 04048266139177 | K140069 | 000 |
| 04048266139184 | K140069 | 000 |
| 04048266139191 | K140069 | 000 |
| 04048266139207 | K140069 | 000 |
| 04048266139214 | K140069 | 000 |
| 04048266139139 | K140069 | 000 |
| 04048266139122 | K140069 | 000 |
| 04048266141538 | K140069 | 000 |
| 04048266141545 | K140069 | 000 |
| 04048266141552 | K140069 | 000 |
| 04048266141569 | K140069 | 000 |
| 04048266139078 | K140069 | 000 |
| 04048266139085 | K140069 | 000 |
| 04048266139092 | K140069 | 000 |
| 04048266139115 | K140069 | 000 |
| 04048266139221 | K140069 | 000 |
| 04048266139238 | K140069 | 000 |
| 04048266140821 | K140069 | 000 |
| 04048266140838 | K140069 | 000 |
| 04048266140852 | K140069 | 000 |
| 04048266140869 | K140069 | 000 |
| 04048266140883 | K140069 | 000 |
| 00841742122366 | K140069 | 000 |
| 00841742122373 | K140069 | 000 |
| 00841742122380 | K140069 | 000 |
| 04048266140807 | K140069 | 000 |
| 04048266140791 | K140069 | 000 |
| 04048266139245 | K140069 | 000 |
| 04048266139252 | K140069 | 000 |
| 04048266139269 | K140069 | 000 |
| 04048266140784 | K140069 | 000 |
| 04048266140814 | K140069 | 000 |
| 04048266140845 | K140069 | 000 |
| 04048266140876 | K140069 | 000 |
| 04048266140777 | K140069 | 000 |
| 04048266139108 | K140069 | 000 |