TS-Bone Hip Plate PDT-125

GUDID 00813892020007

125° Titanium TS Bone Hip Plate

Orthopedic Sciences Inc

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

• Primary Device ID: 00813892020007
• NIH Device Record Key: 46101bc8-e249-46eb-b053-edc2f2110b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TS-Bone Hip Plate
• Version Model Number: PDT-125
• Catalog Number: PDT-125
• 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: 125 degree
• Angle: 125 degree
• Angle: 125 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	00813892020007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063709

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: 2015-09-28

On-Brand Devices [TS-Bone Hip Plate]

• 00813892020083: 45mm TS-Bone Titanium Compression Screw
• 00813892020076: 40mm TS-Bone Titanium Compression Screw
• 00813892020069: 35mm TS-Bone Titanium Compression Screw
• 00813892020052: 30mm TS-Bone Titanium Compression Screw
• 00813892020045: 25mm TS-Bone Titanium Compression Screw
• 00813892020038: 140° Titanium TS-Bone Hip Plate
• 00813892020021: 135° Titanium TS-Bone Hip Plate
• 00813892020014: 130° Titanium TS-Bone Hip Plate
• 00813892020007: 125° Titanium TS Bone Hip Plate