ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM

Screw, Fixation, Bone

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Asnis 2 Small Diameter Cannulated Screw System.

Pre-market Notification Details

Device IDK911398
510k NumberK911398
Device Name:ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
ClassificationScrew, Fixation, Bone
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-29
Decision Date1991-06-27

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