MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE

Plate, Bone

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Manual Surg. Instru. For Steinhauser Bone Plate.

Pre-market Notification Details

Device IDK862533
510k NumberK862533
Device Name:MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE
ClassificationPlate, Bone
Applicant WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
ContactDebra A Powers
CorrespondentDebra A Powers
WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-02
Decision Date1986-08-01

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