INNOVASIVE DEVICES MENISCAL SCREW

Screw, Fixation, Bone

INNOVASIVE DEVICES, INC.

The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Devices Meniscal Screw.

Pre-market Notification Details

Device IDK980681
510k NumberK980681
Device Name:INNOVASIVE DEVICES MENISCAL SCREW
ClassificationScrew, Fixation, Bone
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactEric Bannon
CorrespondentEric Bannon
INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-20
Decision Date1998-04-29
Summary:summary

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