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 |