KangLi Pedicle Screw Spinal System T6290070

GUDID 06937762181989

EF 5.5 Crosslinks 70mm

Suzhou Kangli Orthopaedics Instrument Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06937762181989
• NIH Device Record Key: 7a5af5aa-2dae-460b-83d6-713b68fd909c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KangLi Pedicle Screw Spinal System
• Version Model Number: T6290070
• Catalog Number: T6290070
• 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: 70 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937762181989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140053

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

Moist Heat or Steam Sterilization

[06937762181989]

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 Pedicle Screw Spinal System]

• 06937762191346: KSS 6.0 U-Pedicle Screw φ5.5×45mm
• 06937762191124: KSS 6.0 U-Pedicle Screw φ5.5×50mm
• 06937762189411: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ6.5×25mm
• 06937762189176: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×50mm
• 06937762187325: Rod (φ6.0)
• 06937762186731: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ6.0×25mm
• 06937762186724: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ5.5×25mm
• 06937762186632: KSS 6.0 U-Break-off Pedicle Screw φ7.0×50mm
• 06937762186281: Rod (φ5.5)
• 06937762186199: KSS 6.0 U-Pedicle Screw φ7.5×35mm
• 06937762186182: KSS 6.0 U-Pedicle Screw φ7.5×40mm
• 06937762184355: Rod (φ6.0)
• 06937762184102: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.0×50mm
• 06937762184096: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.0×45mm
• 06937762183969: KSS 6.0 U-Break-off Pedicle Screw φ7.5×45mm
• 06937762183952: KSS 6.0 U-Pedicle Screw φ7.5×45mm
• 06937762183761: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.5×55mm
• 06937762183525: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×55mm
• 06937762183518: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×50mm
• 06937762183501: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×45mm
• 06937762183471: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.5×50mm
• 06937762183464: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.5×45mm
• 06937762182542: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.5×40mm
• 06937762182535: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ7.5×35mm
• 06937762182528: KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ6.5×30mm
• 06937762182511: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.5×50mm
• 06937762182504: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.5×45mm
• 06937762182498: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.5×40mm
• 06937762182481: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.5×35mm
• 06937762182474: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×45mm
• 06937762182467: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×40mm
• 06937762182450: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×35mm
• 06937762182443: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×40mm
• 06937762182436: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×35mm
• 06937762182429: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×30mm
• 06937762182351: KSS 5.5 U-Break-off Pedicle Screw φ7.0×40mm
• 06937762182344: KSS 5.5 U-Break-off Pedicle Screw φ7.0×35mm
• 06937762182337: KSS 5.5 U-Break-off Pedicle Screw φ6.5×50mm
• 06937762182320: KSS 5.5 U-Break-off Pedicle Screw φ6.5×45mm
• 06937762182313: KSS 5.5 U-Break-off Pedicle Screw φ6.5×40mm
• 06937762182306: KSS 5.5 U-Break-off Pedicle Screw φ6.5×35mm
• 06937762182290: KSS 5.5 U-Break-off Pedicle Screw φ6.0×50mm
• 06937762182283: KSS 5.5 U-Break-off Pedicle Screw φ6.0×45mm
• 06937762182276: KSS 5.5 U-Break-off Pedicle Screw φ6.0×40mm
• 06937762182269: KSS 5.5 U-Break-off Pedicle Screw φ6.0×35mm
• 06937762182252: KSS 5.5 U-Break-off Pedicle Screw φ5.5×45mm
• 06937762182245: KSS 5.5 U-Break-off Pedicle Screw φ5.5×35mm
• 06937762182191: KSS 5.5 U-Pedicle Screw φ7.0×40mm
• 06937762182184: KSS 5.5 U-Pedicle Screw φ7.0×35mm
• 06937762182177: KSS 5.5 U-Pedicle Screw φ6.5×55mm