PINN-ACL CPH-8000

GUDID 20845854013646

8MM PINN-ACL CROSS PIN SYSTEM, GRAFT HARNESS WITH CANNULA

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 20845854013646
• NIH Device Record Key: 377cdfaf-4a69-4772-850a-e1c2fe6e10ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINN-ACL
• Version Model Number: CPH-8000
• Catalog Number: CPH-8000
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854013646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043106

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-10-24

On-Brand Devices [PINN-ACL]

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• 20845854013653: PINN-ACL CROSSPIN SYSTEM, 50MM (25MM) CROSSPIN
• 20845854013646: 8MM PINN-ACL CROSS PIN SYSTEM, GRAFT HARNESS WITH CANNULA
• 20845854013639: PINN-ACL CROSSPIN SYSTEM, 40MM (15MM) CROSSPIN
• 20845854034689: 8MM PINN-ACL CROSSPIN POSITIONING ROD
• 20845854034672: PINN-ACL CROSSPIN DRIVER
• 20845854034665: PINN-ACL CROSSPIN U-GUIDE
• 20845854026875: 9MM PINN-ACL CROSSPIN POSITIONING ROD
• 20845854026868: PINN-ACL CROSSPIN DRILL BIT
• 20845854026851: PINN-ACL CROSSPIN STERILIZATION TRAY
• 20845854025519: PINN-ACL CRUCIATE GUIDE