PBP TOTAL HIP SYSTEM

Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

PIPELINE BIOMEDICAL PRODUCTS, LLC

The following data is part of a premarket notification filed by Pipeline Biomedical Products, Llc with the FDA for Pbp Total Hip System.

Pre-market Notification Details

Device IDK122158
510k NumberK122158
Device Name:PBP TOTAL HIP SYSTEM
ClassificationHip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Applicant PIPELINE BIOMEDICAL PRODUCTS, LLC 901 KING STREET SUITE 200 Alexandria,  VA  22314
ContactTerry Powell
CorrespondentTerry Powell
PIPELINE BIOMEDICAL PRODUCTS, LLC 901 KING STREET SUITE 200 Alexandria,  VA  22314
Product CodeOQG  
Subsequent Product CodeJDI
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMEH
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-20
Decision Date2012-12-11
Summary:summary

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