SMR Shoulder - Hybrid Glenoid 9013.79.580

GUDID 08033390124164

Glenosphere Dia. 36 mm Extraction Insert

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390124164
• NIH Device Record Key: efb25f7e-a352-4e13-b5a6-b3c6bf04fb45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR Shoulder - Hybrid Glenoid
• Version Model Number: Glenosphere Extraction Insert
• Catalog Number: 9013.79.580
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390124164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163397

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

[08033390124164]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-07-05

On-Brand Devices [SMR Shoulder - Hybrid Glenoid]

• 08033390124232: Reverse Baseplate Extractor
• 08033390124225: Glenosphere Extractor Handle
• 08033390124188: Glenosphere Dia. 40 mm - Ecc. 40mm Extraction Insert
• 08033390124171: Ecc Glenosphere Dia. 36mm Extraction Insert
• 08033390124164: Glenosphere Dia. 36 mm Extraction Insert
• 08033390124157: Glenosphere Impactor - Orienter
• 08033390123815: Baseplate Extractor
• 08033390123785: Removal Guide LARGE
• 08033390123778: Removal Guide STD
• 08033390123761: Removal Guide SMALL
• 08033390121422: Glenoid Positioner LARGE
• 08033390121415: Glenoid Positioner STD
• 08033390121392: Glenoid Positioner SMALL
• 08033390124065: Drill Guide for Reverse Baseplate
• 08033390123839: Guide for Conversion Glenoid Reamer
• 08033390121347: Glenoid Drill Guide LARGE
• 08033390121330: Glenoid Drill Guide STD
• 08033390121323: Glenoid Drill Guide SMALL
• 08033390180566: Removal Drill Guide
• 08033390180542: Removal Guide LARGE LOW
• 08033390180528: Removal Guide STD LOW
• 08033390180504: Removal Guide SMALL LOW
• 08033390180481: Removal Drill +2mm
• 08033390180412: Removal Drill +0mm
• 08033390124515: Reverse Baseplate Orienter
• 08033390124256: K-Wire Positioning Jig for TT Peg
• 08033390124201: Glenosphere Insertion Guide
• 08033390121408: Central Peg Protector
• 08033390121385: Cement Compactor LARGE
• 08033390121378: Cement Compactor STD
• 08033390121361: Cement Compactor SMALL
• 08033390121316: Compactor L
• 08033390121309: Compactor S