The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Recon System - Mpj-plates.
| Device ID | K152142 |
| 510k Number | K152142 |
| Device Name: | RECON System - MPJ-Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532 |
| Contact | Arne Briest |
| Correspondent | Arne Briest NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024184145 | K152142 | 000 |
| 00889024107106 | K152142 | 000 |
| 00889024107113 | K152142 | 000 |
| 00889024107120 | K152142 | 000 |
| 00889024107847 | K152142 | 000 |
| 00889024107854 | K152142 | 000 |
| 00889024107861 | K152142 | 000 |
| 00889024107878 | K152142 | 000 |
| 00889024107885 | K152142 | 000 |
| 00889024107892 | K152142 | 000 |
| 00889024113190 | K152142 | 000 |
| 00889024184060 | K152142 | 000 |
| 00889024106635 | K152142 | 000 |