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 |