Talon™ Compression Hip Screw System

GUDID B058THS0450541

Cortical Screw, 54mm

Orthopedic Designs North America, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B058THS0450541
• NIH Device Record Key: 2407db4e-1d09-4e40-93f4-5d37a050e054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ Compression Hip Screw System
• Version Model Number: THS045054
• Company DUNS: 945518848
• Company Name: Orthopedic Designs North America, Inc.
• 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: true
• 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

Customer Support Contacts

• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Length: 54 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058THS0450541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984331

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[B058THS0450541]

Moist Heat or Steam Sterilization

[B058THS0450541]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [Talon™ Compression Hip Screw System]

• B058THS1503861: Side Plate, 150 Deg x 38mm, Standard Barrel, 6 Hole
• B058THS1503841: Side Plate, 150 Deg x 38mm, Standard Barrel, 4 Hole
• B058THS1502541: Side Plate, 150 Deg x 25mm, Short Barrel, 4 Hole
• B058THS1453841: Side Plate, 145 Deg x 38mm, Standard Barrel, 4 Hole
• B058THS1403841: Side Plate, 140 Deg x 38mm, Standard Barrel, 4 Hole
• B058THS1353881: Side Plate, 135 Deg x 38mm, Standard Barrel, 8 Hole
• B058THS1353861: Side Plate, 135 Deg x 38mm, Standard Barrel, 6 Hole
• B058THS1353841: Side Plate, 135 Deg x 38mm, Standard Barrel, 4 Hole
• B058THS1353831: Side Plate, 135 Deg x 38mm, Standard Barrel, 3 Hole
• B058THS1353821: Side Plate, 135 Deg x 38mm, Standard Barrel, 2 Hole
• B058THS1352541: Side Plate, 135 Deg x 25mm, Short Barrel, 4 Hole
• B058THS1303841: Side Plate, 130 Deg x 38mm, Standard Barrel, 4 Hole
• B058THS1271251: Talon™ Lag Screw - 12.7mm x 125mm
• B058THS1271201: Talon™ Lag Screw - 12.7mm x 120mm
• B058THS1271151: Talon™ Lag Screw - 12.7mm x 115mm
• B058THS1271101: Talon™ Lag Screw - 12.7mm x 110mm
• B058THS1271051: Talon™ Lag Screw - 12.7mm x 105mm
• B058THS1271001: Talon™ Lag Screw - 12.7mm x 100mm
• B058THS1270951: Talon™ Lag Screw - 12.7mm x 95mm
• B058THS1270901: Talon™ Lag Screw - 12.7mm x 90mm
• B058THS1270851: Talon™ Lag Screw - 12.7mm x 85mm
• B058THS1270801: Talon™ Lag Screw - 12.7mm x 80mm
• B058THS1270751: Talon™ Lag Screw - 12.7mm x 75mm
• B058THS1270701: Talon™ Lag Screw - 12.7mm x 70mm
• B058THS1270651: Talon™ Lag Screw - 12.7mm x 65mm
• B058THS0450561: Cortical Screw, 56mm
• B058THS0450541: Cortical Screw, 54mm
• B058THS0450521: Cortical Screw, 52mm
• B058THS0450501: Cortical Screw, 50mm
• B058THS0450481: Cortical Screw, 48mm
• B058THS0450461: Cortical Screw, 46mm
• B058THS0450441: Cortical Screw, 44mm
• B058THS0450421: Cortical Screw, 42mm
• B058THS0450401: Cortical Screw, 40mm
• B058THS0450381: Cortical Screw, 38mm
• B058THS0450361: Cortical Screw, 36mm
• B058THS0450341: Cortical Screw, 34mm
• B058THS0450321: Cortical Screw, 32mm
• B058THS0450301: Cortical Screw, 30mm
• B058THS0450281: Cortical Screw, 28mm
• B058THS0450261: Cortical Screw, 26mm
• B058THS0040321: Compression Screw, 32mm
• B058THS0040261: Compression Screw, 26mm