BIO-ANCHOR C6120A

GUDID 20845854014322

BIO-ANCHOR, PRE-LOADED 3.5MM X 10.5MM

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 20845854014322
• NIH Device Record Key: 08a9b32f-256a-4414-a5b0-6bf5e3836ac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-ANCHOR
• Version Model Number: C6120A
• Catalog Number: C6120A
• 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

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854014322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983186

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

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: 2016-09-24

On-Brand Devices [BIO-ANCHOR]

• 20845854030797: 3.5 X 10.5MM BIO-ANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE NO. 2 HI-FI SUTURE
• 20845854030780: 3.5MM BIO-ANCHOR WITH DISPOSABLE DRIVER
• 20845854014322: BIO-ANCHOR, PRE-LOADED 3.5MM X 10.5MM