Y-Knot, OneStep Y1S1RK

GUDID 20845854902100

Y-Knot® OneStep™ Anchor, One Ribbon (Black)

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20845854902100
• NIH Device Record Key: 4ecdf4f1-a3e1-4ec0-b0c6-467357476bcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-Knot, OneStep
• Version Model Number: Y1S1RK
• Catalog Number: Y1S1RK
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854902100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193606

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Y-Knot, OneStep]

• 20845854902117: Y-Knot® OneStep™ Anchor, Two Ribbons
• 20845854902100: Y-Knot® OneStep™ Anchor, One Ribbon (Black)
• 20845854902094: Y-Knot® OneStep™ Anchor, One Ribbon (Blue)
• 20845854901851: Y-Knot® OneStep™ Anchor, Two #2 Hi-Fi
• 20845854901844: Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black)
• 10845854902189: Y-Knot® OneStep™ Obturator, Straight, Reusable
• 20845854901837: Y-Knot OneStep Anchor, One No. 2 Hi-Fi (Blue)
• 10845854902172: Y-Knot® OneStep™ Guide, Crown
• 10845854902165: Y-Knot OneStep Guide, Crown Curved
• 10845854902158: Y-Knot OneStep Guide, Fishmouth
• 30845854648661: Y-Knot OneStep Guide, Crown
• 30845854648647: Y-Knot OneStep Guide, Fishmouth
• 20845854083458: Y-Knot® OneStep™ Anchor, Two #2 Hi-Fi
• 20845854083441: Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black)
• 20845854083434: Y-Knot OneStep Anchor, One No. 2 Hi-Fi (Blue)