C2 Hip 9045.16.012

GUDID 08033390071659

C2 Hip - Trial Neck

LIMACORPORATE SPA

Femoral stem prosthesis trial
Primary Device ID08033390071659
NIH Device Record Key75f0ebbc-8206-483c-aa92-b44de2c14ea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 Hip
Version Model Number9045.16.012
Catalog Number9045.16.012
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390071659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390071659]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-05
Device Publish Date2018-03-13

On-Brand Devices [C2 Hip]

08033390071673M8 Stem Beater-Extractor
08033390071666C2 Hip - Lateralized Trial Neck
08033390071659C2 Hip - Trial Neck
08033390066594C2 Hip - Broach # 6
08033390066556C2 Hip - Broach # 2
08033390066549C2 Hip - Broach # 1
08033390066532C2 Hip - Broach # 0
08033390066525C2 Hip - Broach # 01
08033390066655C2 Hip - Broach # 12
08033390066648C2 Hip - Broach # 11
08033390066631C2 Hip - Broach # 10
08033390066624C2 Hip - Broach # 9

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