CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW

Screw, Fixation, Bone

TECHMEDICA, INC.

The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Cancellous Bone-l.p. And Cortical Bone Screw.

Pre-market Notification Details

Device IDK915187
510k NumberK915187
Device Name:CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
ClassificationScrew, Fixation, Bone
Applicant TECHMEDICA, INC. 3760 CALLE TECATE Camarillo,  CA  93012
ContactRichard W Cudworth
CorrespondentRichard W Cudworth
TECHMEDICA, INC. 3760 CALLE TECATE Camarillo,  CA  93012
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-18
Decision Date1991-12-19

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