INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER

Arthroscope

INNOVASIVE DEVICES, INC.

The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Arthroscopic Roc Suture Bone Fastener.

Pre-market Notification Details

Device IDK941273
510k NumberK941273
Device Name:INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER
ClassificationArthroscope
Applicant INNOVASIVE DEVICES, INC. 100 B SOUTH ST. Hopkinton,  MA  01748
ContactEric Bannon
CorrespondentEric Bannon
INNOVASIVE DEVICES, INC. 100 B SOUTH ST. Hopkinton,  MA  01748
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-16
Decision Date1994-09-16

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