CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM

Screw, Fixation, Bone

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Self Compressing Cannulated Screw System.

Pre-market Notification Details

Device IDK872156
510k NumberK872156
Device Name:CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
ClassificationScrew, Fixation, Bone
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactPenny Rasmussen
CorrespondentPenny Rasmussen
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-04
Decision Date1987-07-21

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