The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System.
| Device ID | K051965 | 
| 510k Number | K051965 | 
| Device Name: | OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM | 
| Classification | Rod, Fixation, Intramedullary And Accessories | 
| Applicant | MERETE MEDICAL GMBH 5349 RED LEAF COURT Oviedo, FL 32765 | 
| Contact | Carl Knobloch | 
| Correspondent | Carl Knobloch MERETE MEDICAL GMBH 5349 RED LEAF COURT Oviedo, FL 32765 | 
| Product Code | HSB | 
| CFR Regulation Number | 888.3020 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2005-07-20 | 
| Decision Date | 2006-06-16 | 
| Summary: | summary |