ELIBRA DYNAMIC KNEE BALANCER

Intraoperative Orthopedic Joint Assessment Aid

SYNVASIVE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Elibra Dynamic Knee Balancer.

Pre-market Notification Details

Device IDK070108
510k NumberK070108
Device Name:ELIBRA DYNAMIC KNEE BALANCER
ClassificationIntraoperative Orthopedic Joint Assessment Aid
Applicant SYNVASIVE TECHNOLOGY, INC. P.O. BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
SYNVASIVE TECHNOLOGY, INC. P.O. BOX 7007 Deerfield,  IL  60015
Product CodeONN  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-11
Decision Date2007-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024355606 K070108 000
00889024355590 K070108 000

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