SMR Shoulder 1304.15.200

GUDID 08033390000949

Finned humeral stems - 80mm (Ti6Al4V) dia.20mm

LIMACORPORATE SPA

Press-fit shoulder humeral stem prosthesis
Primary Device ID08033390000949
NIH Device Record Key7b5279fd-01bf-47cc-a1bd-145383e7df40
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Shoulder
Version Model NumberFinned Stem
Catalog Number1304.15.200
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
GS108033390000949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-12
Device Publish Date2015-07-29

On-Brand Devices [SMR Shoulder]

08033390152068Reverse Adaptor Sleeve
08033390122412Adaptor for stem extractor
08033390122320Glenosphere Extractor
08033390122313Glenosphere Impactor
08033390120784Long Stem for Glenosphere Extractor
080333901194983 Pegs Removal Guide #LARGE - SMR Shoulder
080333901194813 Pegs Removal Guide #SMALL - SMR Shoulder
080333901194743 Pegs Removal Guide #STD - SMR Shoulder
080333901194673 Pegs Removal Guide #X-SMALL - SMR Shoulder
08033390115469Glenoid Impactor CMI
08033390099035Glenosphere Impactor-Extractor
08033390098892Reverse Prosthesis Inserter
08033390098328Body Stopper
08033390097598Expansion Extractor
08033390097581Universal Stem for Extractor
08033390097574Threaded Extractor
08033390095426TT Metal Back Impactor
08033390094863Baseplate Extractor
08033390094856SMALL-R Baseplate Extractor
08033390038911Body Stopper
08033390038317Extractor for Metal Back
08033390023528Glenosphere Impactor-Extractor
08033390023429Expansion Extractor
08033390023368Universal Stem for Extractor
08033390023351Extractor for Humeral Body
08033390022989Prosthesis Introducer
08033390022972Extractor for Small-R Metal Back
08033390128568SMR Shoulder - Humeral Body Trial Screw
08033390118194Bone Graft Instrument Set - K-Wire Positioning Jig STD 15°
08033390118187Bone Graft Instrument Set - K-Wire Positioning Jig S 15°
080333901143493 Pegs Glenoid Cement Compactor X-SMALL
08033390114295Mask XS for K-Wire Insertion
08033390108782Bone Graft Instrument Set - Head K-Wire Positioner
08033390103213Trial Mini Stem with Quick Connect. Dia.13 mm
08033390103206Trial Mini Stem with Quick Connect. Dia.12 mm
08033390103190Trial Mini Stem with Quick Connect. Dia.11 mm
08033390095402Mask STD 20° for K-Wire Insertion
08033390095372Mask STD for K-Wire Insertion
08033390095358Mask S 20° for K-Wire Insertion
08033390095327Mask S for K-Wire Insertion
08033390095297Compactor SMALL/STD/LARGE #X-LONG
08033390095280Compactor SMALL/STD/LARGE #LONG
08033390095273Compactor SMALL/STD/LARGE #MEDIUM
08033390095266Compactor SMALL/STD/LARGE #SHORT
08033390095259Compactor SMALL-R #X-LONG
08033390095242Compactor SMALL-R #LONG
08033390095235Compactor SMALL-R #MEDIUM
08033390095228Compactor SMALL-R #SHORT
08033390095204Reamer SMALL/STD/LARGE #X-LONG
08033390095198Reamer SMALL/STD/LARGE #LONG

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