SMR Shoulder 1304.15.200

GUDID 08033390000949

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

LIMACORPORATE SPA

Press-fit shoulder humeral stem prosthesis

• Primary Device ID: 08033390000949
• NIH Device Record Key: 7b5279fd-01bf-47cc-a1bd-145383e7df40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR Shoulder
• Version Model Number: Finned Stem
• Catalog Number: 1304.15.200
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390000949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101263

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-12
• Device Publish Date: 2015-07-29

On-Brand Devices [SMR Shoulder]

• 08033390152068: Reverse Adaptor Sleeve
• 08033390122412: Adaptor for stem extractor
• 08033390122320: Glenosphere Extractor
• 08033390122313: Glenosphere Impactor
• 08033390120784: Long Stem for Glenosphere Extractor
• 08033390119498: 3 Pegs Removal Guide #LARGE - SMR Shoulder
• 08033390119481: 3 Pegs Removal Guide #SMALL - SMR Shoulder
• 08033390119474: 3 Pegs Removal Guide #STD - SMR Shoulder
• 08033390119467: 3 Pegs Removal Guide #X-SMALL - SMR Shoulder
• 08033390115469: Glenoid Impactor CMI
• 08033390099035: Glenosphere Impactor-Extractor
• 08033390098892: Reverse Prosthesis Inserter
• 08033390098328: Body Stopper
• 08033390097598: Expansion Extractor
• 08033390097581: Universal Stem for Extractor
• 08033390097574: Threaded Extractor
• 08033390095426: TT Metal Back Impactor
• 08033390094863: Baseplate Extractor
• 08033390094856: SMALL-R Baseplate Extractor
• 08033390038911: Body Stopper
• 08033390038317: Extractor for Metal Back
• 08033390023528: Glenosphere Impactor-Extractor
• 08033390023429: Expansion Extractor
• 08033390023368: Universal Stem for Extractor
• 08033390023351: Extractor for Humeral Body
• 08033390022989: Prosthesis Introducer
• 08033390022972: Extractor for Small-R Metal Back
• 08033390128568: SMR Shoulder - Humeral Body Trial Screw
• 08033390118194: Bone Graft Instrument Set - K-Wire Positioning Jig STD 15°
• 08033390118187: Bone Graft Instrument Set - K-Wire Positioning Jig S 15°
• 08033390114349: 3 Pegs Glenoid Cement Compactor X-SMALL
• 08033390114295: Mask XS for K-Wire Insertion
• 08033390108782: Bone Graft Instrument Set - Head K-Wire Positioner
• 08033390103213: Trial Mini Stem with Quick Connect. Dia.13 mm
• 08033390103206: Trial Mini Stem with Quick Connect. Dia.12 mm
• 08033390103190: Trial Mini Stem with Quick Connect. Dia.11 mm
• 08033390095402: Mask STD 20° for K-Wire Insertion
• 08033390095372: Mask STD for K-Wire Insertion
• 08033390095358: Mask S 20° for K-Wire Insertion
• 08033390095327: Mask S for K-Wire Insertion
• 08033390095297: Compactor SMALL/STD/LARGE #X-LONG
• 08033390095280: Compactor SMALL/STD/LARGE #LONG
• 08033390095273: Compactor SMALL/STD/LARGE #MEDIUM
• 08033390095266: Compactor SMALL/STD/LARGE #SHORT
• 08033390095259: Compactor SMALL-R #X-LONG
• 08033390095242: Compactor SMALL-R #LONG
• 08033390095235: Compactor SMALL-R #MEDIUM
• 08033390095228: Compactor SMALL-R #SHORT
• 08033390095204: Reamer SMALL/STD/LARGE #X-LONG
• 08033390095198: Reamer SMALL/STD/LARGE #LONG