Prime And DYNASTY® Additive Manufacturing Shells

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

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Prime And Dynasty® Additive Manufacturing Shells.

Pre-market Notification Details

Device IDK202705
510k NumberK202705
Device Name:Prime And DYNASTY® Additive Manufacturing Shells
ClassificationHip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactGillen Gonzales
CorrespondentGillen Gonzales
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeOQG  
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeOQI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2021-08-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684P3SAQG681 K202705 000
M684P3SAQA441 K202705 000
M684P3SAQB461 K202705 000
M684P3SAQB481 K202705 000
M684P3SAQC501 K202705 000
M684P3SAQC521 K202705 000
M684P3SAQD541 K202705 000
M684P3SAQD561 K202705 000
M684P3SAQE581 K202705 000
M684P3SAQE601 K202705 000
M684P3SAQF621 K202705 000
M684P3SAQF641 K202705 000
M684P3SAQG661 K202705 000
M684P3SAQA421 K202705 000

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