CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW

Screw, Fixation, Bone

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Cancellous Fixation Screw & Washer For Use W/screw.

Pre-market Notification Details

Device IDK871037
510k NumberK871037
Device Name:CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW
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 Received1987-03-17
Decision Date1987-03-25

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