Kinematic 6485-4-111

GUDID 07613327048148

Rotating Hinge Knee

Howmedica Osteonics Corp.

Rotating hinged total knee prosthesis

• Primary Device ID: 07613327048148
• NIH Device Record Key: ccebb0ba-73af-461a-8629-9962ed8ba008
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinematic
• Version Model Number: 6485-4-111
• Catalog Number: 6485-4-111
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327048148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002552

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Kinematic]

• 07613327101102: Rotating Hinge Knee
• 07613327048193: Rotating Hinge Knee
• 07613327048186: Rotating Hinge Knee
• 07613327048179: Rotating Hinge Knee
• 07613327048162: Rotating Hinge Knee
• 07613327048155: Rotating Hinge Knee
• 07613327048148: Rotating Hinge Knee
• 07613327047752: Rotating Hinge Knee
• 07613327047745: Rotating Hinge Knee
• 07613327047738: Patella Component
• 07613327047721: Rotating Hinge Knee
• 07613327047714: Rotating Hinge Knee
• 07613327047707: Rotating Hinge Knee
• 07613327047691: Rotating Hinge Knee
• 07613327047684: Rotating Hinge Knee
• 07613327047677: Rotating Hinge Knee
• 07613327047660: Patella Component
• 07613327047653: Rotating Hinge Knee
• 07613327047646: Rotating Hinge Knee
• 07613327047639: Rotating Hinge Knee
• 07613327047622: Rotating Hinge Knee
• 07613327047615: Rotating Hinge Knee
• 07613327047608: Rotating Hinge Knee
• 07613327047592: Rotating Hinge Knee
• 07613327047585: Rotating Hinge Knee
• 07613327047578: Rotating Hinge Knee
• 07613327047561: Rotating Hinge Knee
• 07613327047554: Rotating Hinge Knee
• 07613327047547: Rotating Hinge Knee
• 07613327047530: Rotating Hinge Knee
• 07613327047523: Rotating Hinge Knee
• 07613327047516: Rotating Hinge Knee
• 07613327047509: Rotating Hinge Knee
• 07613327047493: Rotating Hinge Knee
• 07613327047486: Rotating Hinge Knee
• 07613327047479: Rotating Hinge Knee
• 07613327047462: Rotating Hinge Knee
• 07613327047455: Rotating Hinge Knee
• 07613327047448: Patella Component
• 07613327046687: Rotating Hinge Knee
• 07613327046663: Modular Knee
• 07613327046656: Rotating Hinge Knee
• 07613327046649: Modular Knee
• 07613327046632: Modular Knee
• 07613327046625: Modular Knee
• 07613327046618: Condylar Knee
• 07613327046595: Modular Knee
• 07613327046588: Modular Knee
• 07613327046571: Modular Knee
• 07613327046564: Modular Knee