Infinity KFB135

GUDID 10845854901786

Infinity™ Adjustable Loop Button Cradle

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10845854901786
• NIH Device Record Key: bc9e00a5-3e37-4f21-a515-3c56ff32036d
• Commercial Distribution Discontinuation: 2020-12-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Infinity
• Version Model Number: KFB135
• Catalog Number: KFB135
• 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
• 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

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
• 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	10845854901786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191204

FDA Product Code

• MBI: Fastener, fixation, nondegradable, 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: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2019-07-29

On-Brand Devices [Infinity]

• 30845854902329: Infinity Anteromedial Guide Right 9/10mm
• 30845854902312: Infinity Anteromedial Guide Right 7/8mm
• 30845854902305: Infinity Anteromedial Guide Left 9/10mm
• 30845854902299: Infinity Anteromedial Guide Left 7/8mm
• 30845854902282: Infinity Guide Body
• 30845854902275: Infinity 3.5mm All-Inside Guide Sleeve
• 30845854902268: Infinity 2.4mm Guide Sleeve Angled
• 30845854902251: Infinity 2.4mm Guide Sleeve Straight
• 30845854902244: Infinity PCL Tibial Guide
• 30845854902237: Infinity ACL Tibial Tip Guide
• 30845854902220: Infinity ACL Tibial Elbow Guide
• 30845854902213: Infinity ACL Tibial Footprint Guide
• 30845854902206: Infinity ACL/PCL Femoral Footprint Guide
• 30845854902190: Infinity 3.5mm Tunnel Dilator
• 30845854901674: KPS Infinity Insert Tray
• 30845854902060: Infinity Suture Shuttle
• 20845854902049: Infinity Retro-Reamer 12mm
• 20845854902032: Infinity Retro-Reamer 11mm
• 20845854902025: Infinity Retro-Reamer 10mm
• 20845854902018: Infinity Retro-Reamer 9.5mm
• 20845854902001: Infinity Retro-Reamer 9mm
• 20845854901998: Infinity Retro-Reamer 8.5mm
• 20845854901981: Infinity Retro-Reamer 8mm
• 20845854901974: Infinity Retro-Reamer 7.5mm
• 20845854901967: Infinity Retro-Reamer 7mm
• 20845854901950: Infinity Retro-Reamer 6.5mm
• 20845854901943: Infinity Retro-Reamer 6mm
• 30845854901810: Infinity™ 3.5mm Spade Tip Guide Pin
• 30845854648814: Infinity PCL Tibial Guide
• 30845854648784: Infinity Guide Body
• 30845854648777: Infinity ACL/PCL Femoral Footprint Guide
• 30845854648760: Infinity Anteromedial Guide Right 9/10mm
• 20845854901806: Infinity™ Adjustable Free Loop
• 20845854901790: Infinity™ Femoral Adjustable Loop Button
• 10845854901786: Infinity™ Adjustable Loop Button Cradle
• 10845854901779: Infinity™ Large Tibial Button
• 10845854901762: Infinity™ Standard Tibial Button
• 20845854648978: Infinity™ 3.5mm Spade Tip Guide Pin
• 20845854649111: Infinity™ Large Tibial Button
• 20845854649104: Infinity™ Standard Tibial Button
• 20845854649074: Infinity™ Adjustable Loop Button Cradle
• 20845854649067: Infinity™ Femoral Adjustable Loop Button
• 30845854083639: Infinity 3.5mm Tunnel Dilator
• 30845854083578: Infinity Suture Shuttle
• 20845854083564: Infinity Retro-Reamer 12mm
• 20845854083557: Infinity Retro-Reamer 11mm
• 20845854083540: Infinity Retro-Reamer 10mm
• 20845854083472: Infinity Retro-Reamer 6.5mm
• 20845854083465: Infinity Retro-Reamer 6mm
• 10845854648841: Infinity 2.4mm Guide Sleeve Angled