SMR System 1321.09.426

GUDID 08033390273817

SMR System - Humeral Head Dia. 42 mm H. 13 mm Eccentrical 6mm

LIMACORPORATE SPA

Stem-fixed humeral head prosthesis

Primary Device ID	08033390273817
NIH Device Record Key	625b8397-9643-4a7f-ac6a-d1240f362a55
Commercial Distribution Status	In Commercial Distribution
Brand Name	SMR System
Version Model Number	1321.09.426
Catalog Number	1321.09.426
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390273817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161476

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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-06
Device Publish Date	2024-02-27

On-Brand Devices [SMR System]

08033390164665	Trial Safety Screw for glenosphere
08033390164368	CMI Reamer Guide
08033390163873	Wrench Torx T15
08033390194617	Stop Guide 30° +5mm
08033390270670	SMR System - Glenoid Peg TT Small/Standard X-Long
08033390270656	SMR System - Glenoid Peg TT Small/Standard Long
08033390270649	SMR System - Glenoid Peg TT Small/Standard Medium
08033390270571	SMR System - Glenoid Peg TT Small/Standard Short
08033390270564	SMR System - Glenoid Peg TT Small-R X-Long
08033390270557	SMR System - Glenoid Peg TT Small-R Long
08033390270540	SMR System - Glenoid Peg TT Small-R Medium
08033390270533	SMR System - Glenoid Peg TT Small-R Short
08033390274555	SMR System - Humeral Head Dia. 54 mm H. 24 mm
08033390274548	SMR System - Humeral Head Dia. 52 mm H. 23 mm
08033390274531	SMR System - Humeral Head Dia. 50 mm H. 22 mm
08033390274524	SMR System - Humeral Head Dia. 48 mm H. 21 mm
08033390274517	SMR System - Humeral Head Dia. 46 mm H. 20 mm
08033390274494	SMR System - Humeral Head Dia. 44 mm H. 19 mm
08033390274487	SMR System - Humeral Head Dia. 42 mm H. 18 mm
08033390274470	SMR System - Humeral Head Dia. 40 mm H. 18 mm
08033390274463	SMR System - Humeral Head Dia. 54 mm H. 23 mm
08033390274456	SMR System - Humeral Head Dia. 52 mm H. 22 mm
08033390274449	SMR System - Humeral Head Dia. 50 mm H. 21 mm
08033390274432	SMR System - Humeral Head Dia. 54 mm H. 18 mm
08033390274425	SMR System - Humeral Head Dia. 48 mm H. 20 mm
08033390274401	SMR System - Humeral Head Dia. 46 mm H. 19 mm
08033390274357	SMR System - Humeral Head Dia. 44 mm H. 18 mm
08033390274340	SMR System - Humeral Head Dia. 42 mm H. 17 mm
08033390274326	SMR System - Humeral Head Dia. 40 mm H. 17 mm
08033390274319	SMR System - Humeral Head Dia. 54 mm
08033390274302	SMR System - Humeral Head Dia. 52 mm H. 17 mm
08033390274296	SMR System - Humeral Head Dia. 52 mm
08033390274289	SMR System - Humeral Head Dia. 50 mm H. 16mm
08033390274272	SMR System - Humeral Head Dia. 50 mm
08033390274265	SMR System - Humeral Head Dia. 48 mm H. 15 mm
08033390274258	SMR System - Humeral Head Dia. 48 mm
08033390274241	SMR System - Humeral Head Dia. 46 mm H. 14 mm
08033390274234	SMR System - Humeral Head Dia. 46 mm
08033390274197	SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 7mm
08033390274166	SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 6mm
08033390274159	SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 4mm
08033390274142	SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 2mm
08033390274081	SMR System - Humeral Head Dia. 44 mm H. 13 mm Neutral
08033390274074	SMR System - Humeral Head Dia. 44 mm
08033390274067	SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 6mm
08033390274050	SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 4mm
08033390274043	SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 2mm
08033390274036	SMR System - Humeral Head Dia. 42 mm H. 12 mm Neutral
08033390274029	SMR System - Humeral Head Dia. 42 mm
08033390274012	SMR System - Humeral Head Dia. 40 mm H. 12 mm Eccentrical 4mm