Variable Angle Non-Locking Screw

GUDID 00840118101578

Implants for orthopedic bone fixation. Also Called a Bone Screw.

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118101578
• NIH Device Record Key: 3e82a4a8-6be6-4aec-bbc7-adb3b36217b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Angle Non-Locking Screw
• Version Model Number: FBS 412
• 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: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118101578 [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 Non-Locking Screw]

• 00840118101516: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109895: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109888: Implants for orthopedic bone fixation. Also called a Bone Screw.
• 00840118109871: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109864: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109857: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109840: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109833: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109826: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109819: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109802: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109796: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118104951: implants for orthopedic bone fixation
• 00840118104944: implants for orthopedic bone fixation
• 00840118104937: implants for orthopedic bone fixation
• 00840118104920: implants for orthopedic bone fixation
• 00840118104913: implants for orthopedic bone fixation
• 00840118104906: implants for orthopedic bone fixation
• 00840118104890: implants for orthopedic bone fixation
• 00840118104883: implants for orthopedic bone fixation
• 00840118104876: implants for orthopedic bone fixation
• 00840118104869: implants for orthopedic bone fixation
• 00840118104852: implants for orthopedic bone fixation
• 00840118104845: implants for orthopedic bone fixation
• 00840118104838: implants for orthopedic bone fixation
• 00840118104821: implants for orthopedic bone fixation
• 00840118104814: implants for orthopedic bone fixation
• 00840118104807: implants for orthopedic bone fixation
• 00840118104791: implants for orthopedic bone fixation
• 00840118104784: implants for orthopedic bone fixation
• 00840118104777: implants for orthopedic bone fixation
• 00840118104760: implants for orthopedic bone fixation
• 00840118104494: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118104487: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101837: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101820: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101813: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101806: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101790: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101783: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101776: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101769: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101752: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101745: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101738: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101721: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101714: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101707: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101691: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101684: Implants for orthopedic bone fixation. Also Called a Bone Screw.