LUHR MINI BONE SCREW AND Z PLATE

Plate, Fixation, Bone

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Luhr Mini Bone Screw And Z Plate.

Pre-market Notification Details

Device IDK935448
510k NumberK935448
Device Name:LUHR MINI BONE SCREW AND Z PLATE
ClassificationPlate, 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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-12
Decision Date1994-02-23

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