EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS

Screw, Fixation, Bone

ELECTRO-BIOLOGY, INC.

The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Xfix Dynafix System Ha Coated Screws.

Pre-market Notification Details

Device IDK992367
510k NumberK992367
Device Name:EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
ClassificationScrew, Fixation, Bone
Applicant ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. Parsippany,  NJ  07054
ContactJonas Wilf
CorrespondentJonas Wilf
ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. Parsippany,  NJ  07054
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-15
Decision Date1999-09-23
Summary:summary

NIH GUDID Devices

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