MEMORY STAPLE (20 SIZES AVAILABLE)

Staple, Fixation, Bone

LANDOS, INC.

The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Memory Staple (20 Sizes Available).

Pre-market Notification Details

Device IDK964226
510k NumberK964226
Device Name:MEMORY STAPLE (20 SIZES AVAILABLE)
ClassificationStaple, Fixation, Bone
Applicant LANDOS, INC. 9109 COPENHAVER DR. Potomac,  MD  20854
ContactNorman F Estrin, Ph.d. Roc
CorrespondentNorman F Estrin, Ph.d. Roc
LANDOS, INC. 9109 COPENHAVER DR. Potomac,  MD  20854
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-23
Decision Date1997-08-05
Summary:summary

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