Titanium-TSY™ Shoulder Plate TSP-130

GUDID 00813892020748

130° Titanium-TSY™ Shoulder Plate

Orthopedic Sciences Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00813892020748
• NIH Device Record Key: 5a2eea7c-58ae-414e-b6f2-ee0f3e2fabd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanium-TSY™ Shoulder Plate
• Version Model Number: TSP-130
• Catalog Number: TSP-130
• Company DUNS: 068109169
• Company Name: Orthopedic Sciences Inc
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(562)799-5550
• Email: info@orthopedicsciences.com
• Phone: +1(562)799-5550
• Email: info@orthopedicsciences.com
• Phone: +1(562)799-5550
• Email: info@orthopedicsciences.com

Device Dimensions

• Angle: 130 degree
• Angle: 130 degree
• Angle: 130 degree

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813892020748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063033

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-05

On-Brand Devices [Titanium-TSY™ Shoulder Plate]

• 00813892020762: 140° Titanium-TSY™ Shoulder Plate
• 00813892020755: 135° Titanium-TSY™ Shoulder Plate
• 00813892020748: 130° Titanium-TSY™ Shoulder Plate
• 00813892020731: 125° Titanium-TSY™ Shoulder Plate
• 00813892020724: 35mm Titanium Compression Screw
• 00813892020717: 30mm Titanium Compression Screw
• 00813892020700: 25mm Titanium Compression Screw
• 00813892020694: 22.5mm Titanium Compression Screw
• 00813892020687: 20mm Titanium Compression Screw
• 00813892020540: 17.5mm Titanium Compression Screw
• 00813892020533: 15mm Titanium Compression Screw