SMR LATERALIZED CONNECTOR 1374.15.325

GUDID 08033390152174

Connector Lat +5 mm + Screw - SMALL/STD

LIMACORPORATE SPA

Reverse shoulder prosthesis head

• Primary Device ID: 08033390152174
• NIH Device Record Key: 39b2b3ea-ac9c-4f9a-989b-ee4f3530c994
• Commercial Distribution Discontinuation: 2024-07-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SMR LATERALIZED CONNECTOR
• Version Model Number: 1374.15.325
• Catalog Number: 1374.15.325
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390152174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183042

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-26
• Device Publish Date: 2019-02-09

Devices Manufactured by LIMACORPORATE SPA

• 08033390001373 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.42mm
• 08033390001380 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.44mm
• 08033390001397 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.46mm
• 08033390001403 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.48mm
• 08033390001410 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.50mm
• 08033390001427 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.52mm
• 08033390001434 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.54mm
• 08033390001557 - SMR Shoulder: 2025-03-06 CTA humeral heads (CoCrMo) dia.42mm