KangLi Locking Plates System T4071014

GUDID 06937762166559

Tibial Locking Plates 14 holes

Suzhou Kangli Orthopaedics Instrument Co.,Ltd.

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

• Primary Device ID: 06937762166559
• NIH Device Record Key: 544cfbdf-75ca-4a24-85ef-7ff37a1b4f50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KangLi Locking Plates System
• Version Model Number: T4071014
• Catalog Number: T4071014
• Company DUNS: 527054774
• Company Name: Suzhou Kangli Orthopaedics Instrument 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: false
• Manufacturing Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 265 Millimeter
• Device Size Text, specify: 0
• Length: 265 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937762166559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133840

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[06937762166559]

Moist Heat or Steam Sterilization

[06937762166559]

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: 2016-09-03

On-Brand Devices [KangLi Locking Plates System]

• 06937762178033: Tibial Locking Plates 16 holes
• 06937762166559: Tibial Locking Plates 14 holes
• 06937762166535: Tibial Locking Plates 12 holes
• 06937762166511: Tibial Locking Plates 10 holes
• 06937762166504: Tibial Locking Plates 9 holes
• 06937762166498: Tibial Locking Plates 8 holes
• 06937762166481: Tibial Locking Plates 7 holes
• 06937762166474: Tibial Locking Plates 6 holes