WARSAW ORTHOPEDIC BONE PLATE

Plate, Fixation, Bone

WARSAW ORTHOPEDIC, INC.

The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Warsaw Orthopedic Bone Plate.

Pre-market Notification Details

Device IDK862254
510k NumberK862254
Device Name:WARSAW ORTHOPEDIC BONE PLATE
ClassificationPlate, Fixation, Bone
Applicant WARSAW ORTHOPEDIC, INC. PAMELA M. BUCKMAN 921 CALLE VERDE Martinez,  CA  94553
ContactBuckman Co.,inc.
CorrespondentBuckman Co.,inc.
WARSAW ORTHOPEDIC, INC. PAMELA M. BUCKMAN 921 CALLE VERDE Martinez,  CA  94553
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-13
Decision Date1986-07-08

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