GUERRERO - BELL DISTRACTOR

Plate, Bone

HOWMEDICA LEIBINGER, INC.

The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Guerrero - Bell Distractor.

Pre-market Notification Details

Device IDK972166
510k NumberK972166
Device Name:GUERRERO - BELL DISTRACTOR
ClassificationPlate, Bone
Applicant HOWMEDICA LEIBINGER, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactJohn F Dichiara
CorrespondentJohn F Dichiara
HOWMEDICA LEIBINGER, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-09
Decision Date1997-08-11
Summary:summary

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