MicroPort CoCr Femoral Heads

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Microport Cocr Femoral Heads.

Pre-market Notification Details

Device IDK190123
510k NumberK190123
Device Name:MicroPort CoCr Femoral Heads
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactTejas Patel
CorrespondentTejas Patel
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-25
Decision Date2019-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684260136XXWD1 K190123 000
M68426010006WD1 K190123 000
M684260100111 K190123 000
M68426010011WD1 K190123 000
M684260136LG1 K190123 000
M684260136LGWD1 K190123 000
M684260136MD1 K190123 000
M684260136MDWD1 K190123 000
M684260136SH1 K190123 000
M684260136SHWD1 K190123 000
M684260136XL1 K190123 000
M684260136XLWD1 K190123 000
M684260136XS1 K190123 000
M684260136XSWD1 K190123 000
M684260136XX1 K190123 000
M684260100061 K190123 000

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