Set Screw

GUDID 06912547138273

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06912547138273
• NIH Device Record Key: bd25f3a8-a410-4802-a05c-1df29ca56205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set Screw
• Version Model Number: 8422500
• Company DUNS: 545249039
• Company Name: Shandong Weigao Orthopaedic Device Co., Ltd.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06912547138273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160320

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[06912547138273]

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: 2016-07-15

On-Brand Devices [Set Screw]

• 06912547394914: 8421500
• 06912547138273: 8422500