NEO KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

PIPELINE ORTHOPEDICS

The following data is part of a premarket notification filed by Pipeline Orthopedics with the FDA for Neo Knee System.

Pre-market Notification Details

Device IDK131368
510k NumberK131368
Device Name:NEO KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria,  VA  22314
ContactTerry Powell
CorrespondentTerry Powell
PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria,  VA  22314
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-13
Decision Date2013-10-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.