TEMA Elbow 1590.15.020

GUDID 08033390128872

Axle Large

LIMACORPORATE SPA

Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis

• Primary Device ID: 08033390128872
• NIH Device Record Key: 0c97813c-69d7-4b0b-b9ba-9cab7be06f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMA Elbow
• Version Model Number: 1590.15.020
• Catalog Number: 1590.15.020
• 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	08033390128872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181362

FDA Product Code

• JDB: Prosthesis, Elbow, Semi-Constrained, Cemented

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: 2021-05-19
• Device Publish Date: 2021-05-11

On-Brand Devices [TEMA Elbow]

• 08033390148245: Flexible Reamer Dia. 5.5 mm
• 08033390148238: Flexible Reamer Dia. 5 mm
• 08033390148221: Flexible Reamer Dia. 4.5 mm
• 08033390147255: Stem for Ulnar Liner Extraction
• 08033390147248: Guide for Ulnar Liner Extraction
• 08033390147231: Control Gauge for Implant Positioning – RIGHT
• 08033390147224: Control Gauge for Implant Positioning – LEFT
• 08033390145695: Humeral Press Adaptor
• 08033390140362: Ulnar Liner small right
• 08033390140324: Ulnar Stem U6.5
• 08033390140317: Ulnar Stem U6
• 08033390140300: Ulnar Stem U5.5
• 08033390140294: Ulnar Liner large right
• 08033390140287: Humeral Body large right
• 08033390140263: Humeral Stem H10 right
• 08033390140256: Humeral Stem H9 right
• 08033390140249: Humeral Stem H9 left
• 08033390140232: Humeral Stem H8 right
• 08033390140225: Humeral Stem H8 left
• 08033390140218: Humeral Stem H7 right
• 08033390140201: Humeral Stem H7 left
• 08033390140171: Humeral Stem H6 right
• 08033390140126: Trial Ulnar Body + Liner Large - RIGHT
• 08033390140119: Trial Ulnar Body + Liner Small - RIGHT
• 08033390140102: Trial Ulnar Body + Liner Large - LEFT
• 08033390140096: Trial Ulnar Body + Liner Small - LEFT
• 08033390140089: Ulnar Body large right
• 08033390140072: Ulnar Body large left
• 08033390140065: Humeral Body small right
• 08033390140058: Ulnar Body small right
• 08033390139335: Ulnar Broach #U8 - RIGHT
• 08033390139328: Ulnar Broach #U8 - LEFT
• 08033390139311: Ulnar Broach #U7.5 - RIGHT
• 08033390139304: Ulnar Broach #U7.5 - LEFT
• 08033390139298: Distal Humeral Broach ##H11/12 - RIGHT
• 08033390139281: Distal Humeral Broach #H11/12 - LEFT
• 08033390139274: Proximal Humeral Broach #H12
• 08033390139267: Proximal Humeral Broach #H11
• 08033390139250: Stem for Humeral in Vivo Taper Assembler
• 08033390139236: Stem for Taper Breakers
• 08033390139229: Counter Torque for Axle Insertion
• 08033390139212: Slap Hammer
• 08033390139205: Ulnar Implant Extractor
• 08033390139199: Ulnar Implant Impactor
• 08033390139144: Ulnar Poly Bearing Press
• 08033390139137: Ulnar Stem Extractor
• 08033390139120: Axle Extractor
• 08033390139113: Ulnar Taper Breaker - RIGHT
• 08033390139106: Ulnar Taper Breaker - LEFT
• 08033390139090: Humeral Taper Breaker - RIGHT