CentLoc Total Knee System 7131-0811

GUDID 08800036801730

CentLoc Tibial insert component PS type Size6-1 11mm

RootLoc Co., Ltd.

Femur/tibia shaft prosthesis

• Primary Device ID: 08800036801730
• NIH Device Record Key: fbaa3ee9-1974-4ebb-a0bb-ad282cb14929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CentLoc Total Knee System
• Version Model Number: 7131-0811
• Catalog Number: 7131-0811
• 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	08800036801730 [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: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [CentLoc Total Knee System]

• 08800036800337: CentLoc Femoral component PS type Right Size9
• 08800036800320: CentLoc Femoral component PS type Right Size9-1
• 08800036800313: CentLoc Femoral component PS type Right Size8
• 08800036800306: CentLoc Femoral component PS type Right Size8-3
• 08800036800290: CentLoc Femoral component PS type Right Size8-2
• 08800036800283: CentLoc Femoral component PS type Right Size8-1
• 08800036800276: CentLoc Femoral component PS type Right Size7
• 08800036800269: CentLoc Femoral component PS type Right Size7-1
• 08800036800252: CentLoc Femoral component PS type Right Size6
• 08800036800245: CentLoc Femoral component PS type Right Size6-1
• 08800036800238: CentLoc Femoral component PS type Right Size6N
• 08800036800221: CentLoc Femoral component PS type Right Size5
• 08800036800214: CentLoc Femoral component PS type Right Size4-1
• 08800036800207: CentLoc Femoral component PS type Right Size4
• 08800036800191: CentLoc Femoral component PS type Right Size3
• 08800036800184: CentLoc Femoral component PS type Right Size2
• 08800036800177: CentLoc Femoral component PS type Right Size1
• 08800036800160: CentLoc Femoral component PS type Left Size9
• 08800036800153: CentLoc Femoral component PS type Left Size9-1
• 08800036800146: CentLoc Femoral component PS type Left Size8
• 08800036800139: CentLoc Femoral component PS type Left Size8-3
• 08800036800122: CentLoc Femoral component PS type Left Size8-2
• 08800036800115: CentLoc Femoral component PS type Left Size8-1
• 08800036800108: CentLoc Femoral component PS type Left Size7
• 08800036800092: CentLoc Femoral component PS type Left Size7-1
• 08800036800085: CentLoc Femoral component PS type Left Size6
• 08800036800078: CentLoc Femoral component PS type Left Size6-1
• 08800036800061: CentLoc Femoral component PS type Left Size6N
• 08800036800054: CentLoc Femoral component PS type Left Size5
• 08800036800047: CentLoc Femoral component PS type Left Size4-1
• 08800036800030: CentLoc Femoral component PS type Left Size4
• 08800036800023: CentLoc Femoral component PS type Left Size3
• 08800036800016: CentLoc Femoral component PS type Left Size 2
• 08800036800009: CentLoc Femoral component PS type Left Size1
• 08800036800825: CentLoc Tibial tray component CCM Size9
• 08800036800818: CentLoc Tibial tray component CCM Size8-4
• 08800036800801: CentLoc Tibial tray component CCM Size8-3
• 08800036800795: CentLoc Tibial tray component CCM Size8-2
• 08800036800788: CentLoc Tibial tray component CCM Size8-1
• 08800036800771: CentLoc Tibial tray component CCM Size8
• 08800036800764: CentLoc Tibial tray component CCM Size7
• 08800036800757: CentLoc Tibial tray component CCM Size6-1
• 08800036800740: CentLoc Tibial tray component CCM Size6
• 08800036800733: CentLoc Tibial tray component CCM Size5
• 08800036800726: CentLoc Tibial tray component CCM Size4-1
• 08800036800719: CentLoc Tibial tray component CCM Size4
• 08800036800702: CentLoc Tibial tray component CCM Size3
• 08800036800696: CentLoc Tibial tray component CCM Size2
• 08800036800689: CentLoc Tibial tray component CCM Size1
• 08800036800672: CentLoc Femoral component CR type Right Size9