MPO Hip Instruments

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Mpo Hip Instruments.

Pre-market Notification Details

Device IDK213816
510k NumberK213816
Device Name:MPO Hip Instruments
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactGillen Gonzales
CorrespondentGillen Gonzales
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeJDI  
Subsequent Product CodeHWC
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMBL
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-07
Decision Date2022-01-05

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.