SPINAL MICROKNIFE

Knife, Orthopedic

KARLIN TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Karlin Technology, Inc. with the FDA for Spinal Microknife.

Pre-market Notification Details

Device IDK882525
510k NumberK882525
Device Name:SPINAL MICROKNIFE
ClassificationKnife, Orthopedic
Applicant KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey,  CA  90292
ContactMark Weidhaas
CorrespondentMark Weidhaas
KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey,  CA  90292
Product CodeHTS  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-17
Decision Date1988-09-22

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