ORTHO-PRO CANNULATED BONE SCREWS

Screw, Fixation, Bone

ORTHO-PRO LLC

The following data is part of a premarket notification filed by Ortho-pro Llc with the FDA for Ortho-pro Cannulated Bone Screws.

Pre-market Notification Details

Device IDK042310
510k NumberK042310
Device Name:ORTHO-PRO CANNULATED BONE SCREWS
ClassificationScrew, Fixation, Bone
Applicant ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-25
Decision Date2004-09-16
Summary:summary

NIH GUDID Devices

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