Evolution Revision CCK System EFCCN5RL

GUDID M684EFCCN5RL1

Microport Orthopedics Inc.

Uncoated knee femur prosthesis, metallic
Primary Device IDM684EFCCN5RL1
NIH Device Record Keydee83acd-99e0-4c2b-920a-d90fa95b336c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolution Revision CCK System
Version Model NumberEFCCN5RL
Catalog NumberEFCCN5RL
Company DUNS079118736
Company NameMicroport Orthopedics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM684EFCCN5RL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2018-04-23

On-Brand Devices [Evolution Revision CCK System]

M684EFCCN8RR1EFCCN8RR
M684EFCCN8RL1EFCCN8RL
M684EFCCN7RR1EFCCN7RR
M684EFCCN7RL1EFCCN7RL
M684EFCCN6RR1EFCCN6RR
M684EFCCN6RL1EFCCN6RL
M684EFCCN5RR1EFCCN5RR
M684EFCCN5RL1EFCCN5RL
M684EFCCN4RR1EFCCN4RR
M684EFCCN4RL1EFCCN4RL
M684EFCCN3RR1EFCCN3RR
M684EFCCN3RL1EFCCN3RL
M684EFCCN2RR1EFCCN2RR
M684EFCCN2RL1EFCCN2RL
M684EFCCN1RR1EFCCN1RR
M684EFCCN1RL1EFCCN1RL
M684ESRF08251ESRF0825
M684ESRF04251ESRF0425
M684E50041101E5004110
M684E50041051E5004105
M684E50031121E5003112
M684E50031081E5003108
M684E50031041E5003104
M684E50010111E5001011
M684E12001171E1200117
M684E11010061E1101006

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