Search Results

Fracture fixation of long bone diaphysis (tibia, humerus, femur) and fracture reduction at metaphyseal and epiphyseal levels.

Pediatric Intramedullary Nail

This FDA letter acknowledges the substantial equivalence of the "MacMed Paediatric Intramedullary Nail" (K991877) to legally marketed predicate devices, thereby allowing its commercialization. However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter is solely a regulatory approval based on the comparison to existing devices, not a review of clinical or performance data as would be found in a study report. Therefore, I cannot provide the requested information from this document.

To answer your questions, you would need access to the original 510(k) submission (K991877) from InnerVision®, Inc., which would have included the technical and performance data supporting their claim of substantial equivalence.

Ask a specific question about this device