CentLoc Total Knee Systerm 7122-4771

GUDID 08800036800900

CentLoc Tibial tray component Ti6Al4V Size6-1

RootLoc Co., Ltd.

Femur/tibia shaft prosthesis

• Primary Device ID: 08800036800900
• NIH Device Record Key: e91f7761-9063-4090-84f7-3a8d56c640a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CentLoc Total Knee Systerm
• Version Model Number: 7122-4771
• Catalog Number: 7122-4771
• Company DUNS: 694670830
• Company Name: RootLoc 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 Identifiers

Device Issuing Agency	Device ID
GS1	08800036800900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182370

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-27
• Device Publish Date: 2019-09-19

Devices Manufactured by RootLoc Co., Ltd.

• 08800036803215 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 9mm
• 08800036803222 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 10mm
• 08800036803239 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 11mm
• 08800036803246 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 12mm
• 08800036803253 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 13mm
• 08800036803260 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 14mm
• 08800036803277 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 14.5mm
• 08800036803284 - CentLoc Total Knee System: 2019-10-03 CentLoc Tibial insert component CR type Size4-1 16mm