The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Recon System-v-tek-ivp Plates And Screws.
| Device ID | K152312 |
| 510k Number | K152312 |
| Device Name: | RECON System-V-TEK-IVP Plates And Screws |
| 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 | 2015-08-17 |
| Decision Date | 2015-10-30 |
| Summary: | summary |