DC ULNAR SHORTENING SYSTEM

Plate, Fixation, Bone

ORTHOPRO LLC

The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Dc Ulnar Shortening System.

Pre-market Notification Details

Device IDK073228
510k NumberK073228
Device Name:DC ULNAR SHORTENING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-15
Decision Date2008-02-29
Summary:summary

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