TEMA Elbow 1590.15.010

GUDID 08033390128865

Axle Small

LIMACORPORATE SPA

Hinged total elbow prosthesis

• Primary Device ID: 08033390128865
• NIH Device Record Key: b70b6a54-a9b8-44ed-825c-76e2159fde87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMA Elbow
• Version Model Number: 1590.15.010
• Catalog Number: 1590.15.010
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390128865 [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