SMR Metal Back 1375.21.010

GUDID 08033390080453

Metal-back (Ti6Al4V + PoroTi) Standard

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID08033390080453
NIH Device Record Key7e26843a-4b21-4947-ad65-35a89450673e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Metal Back
Version Model NumberUncemented Glenoid
Catalog Number1375.21.010
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390080453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2015-08-04

On-Brand Devices [SMR Metal Back ]

08033390080477Metal-back (Ti6Al4V + PoroTi) Large
08033390080460Metal-back (Ti6Al4V + PoroTi) Small
08033390080453Metal-back (Ti6Al4V + PoroTi) Standard
08033390080446Metal-back (Ti6Al4V + PoroTi) Small-R
08033390071772Cementless Glenoids (Ti6Al4V + PoroTi) metal-back Large
08033390071765Cementless Glenoids (Ti6Al4V + PoroTi) metal-back Standard
08033390071758Cementless Glenoids (Ti6Al4V + PoroTi) metal-back Small
08033390071741Cementless Glenoids (Ti6Al4V + PoroTi) metal-back Small-R

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