The following data is part of a premarket notification filed by Mahe Medical Gmbh with the FDA for Mahe Fixation Plate And Screw System.
| Device ID | K102845 |
| 510k Number | K102845 |
| Device Name: | MAHE FIXATION PLATE AND SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
| Product Code | HRS |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-05-13 |
| Summary: | summary |