KangLi Locking Plates System T4071012

GUDID 06937762166535

Tibial Locking Plates 12 holes

Suzhou Kangli Orthopaedics Instrument Co.,Ltd.

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

Primary Device ID	06937762166535
NIH Device Record Key	cc884785-fc6c-4d29-92f4-bdf4f6af7df9
Commercial Distribution Status	In Commercial Distribution
Brand Name	KangLi Locking Plates System
Version Model Number	T4071012
Catalog Number	T4071012
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

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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
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Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter
Device Size Text, specify	0
Length	223 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937762166535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133840

FDA Product Code

HWC	Screw, Fixation, Bone