Variable Angle Locking Peg

GUDID 00840118110037

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118110037
• NIH Device Record Key: 36e83208-0a64-4b4b-b00c-8804aea9b07e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Angle Locking Peg
• Version Model Number: FLP 116
• Company DUNS: 078790947
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• 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

Customer Support Contacts

• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com

Device Dimensions

• Outer Diameter: 1.8 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 1.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118110037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131657

FDA Product Code

• HWC: Screw, 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: 2015-09-15

On-Brand Devices [Variable Angle Locking Peg]

• 00840118110891: implants for orthopedic bone fixation
• 00840118110884: implants for orthopedic bone fixation
• 00840118110877: implants for orthopedic bone fixation
• 00840118110860: implants for orthopedic bone fixation
• 00840118110082: implants for orthopedic bone fixation
• 00840118110075: implants for orthopedic bone fixation
• 00840118110068: implants for orthopedic bone fixation
• 00840118110051: implants for orthopedic bone fixation
• 00840118110044: implants for orthopedic bone fixation
• 00840118110037: implants for orthopedic bone fixation
• 00840118110020: implants for orthopedic bone fixation