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 |