Curved Connection Rod

GUDID 06912547394495

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06912547394495
• NIH Device Record Key: d7ff1455-46b2-40c8-af9b-033d52865800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Connection Rod
• Version Model Number: 803805045
• 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	06912547394495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170861

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

Moist Heat or Steam Sterilization

[06912547394495]

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: 2017-12-12

On-Brand Devices [Curved Connection Rod]

• 06912547394662: 803805150
• 06912547394655: 803805140
• 06912547394648: 803805130
• 06912547394631: 803805120
• 06912547394624: 803805110
• 06912547394617: 803805105
• 06912547394600: 803805100
• 06912547394594: 803805095
• 06912547394587: 803805090
• 06912547394570: 803805085
• 06912547394563: 803805080
• 06912547394556: 803805075
• 06912547394549: 803805070
• 06912547394532: 803805065
• 06912547394525: 803805060
• 06912547394518: 803805055
• 06912547394501: 803805050
• 06912547394495: 803805045
• 06912547394488: 803805040
• 06912547394471: 803805035
• 06912547394464: 803805030
• 06912547394457: 803805025