Integra DigiFuse Cannulated Intramedullary Fusion System

Screw, Fixation, Bone

Ascension Orthopedics

The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra Digifuse Cannulated Intramedullary Fusion System.

Pre-market Notification Details

Device IDK152527
510k NumberK152527
Device Name:Integra DigiFuse Cannulated Intramedullary Fusion System
ClassificationScrew, Fixation, Bone
Applicant Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin,  TX  78754
ContactJayana Kenana
CorrespondentJayana Kenana
Integra LifeSciences 311 Enterprise Drive Plainsboro,  NJ  08536
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-03
Decision Date2015-10-29
Summary:summary

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