ABSOLUTE ABSORBABLE INTERFERENCE 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 Absolute Absorbable Interference Screw.

Pre-market Notification Details

Device IDK993975
510k NumberK993975
Device Name:ABSOLUTE ABSORBABLE INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactKathleen Morahan
CorrespondentKathleen Morahan
INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-24
Decision Date1999-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705013067 K993975 000

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