MITEK TIGHT-N 208882

GUDID 10886705032655

MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor MEDIUM 7.0mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705032655
• NIH Device Record Key: a5539371-44ed-406a-bf24-9a2a8b1ac7fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MITEK TIGHT-N
• Version Model Number: 208882
• Catalog Number: 208882
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705032655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221364

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: 2022-11-21
• Device Publish Date: 2022-11-11

On-Brand Devices [MITEK TIGHT-N]

• 10886705032716: MITEK TIGHT-N Tendon Docking Anchor Implant Sizer
• 10886705032709: MITEK TIGHT-N Tendon Docking Anchor Self Piloting Reamer LARGE 8.5 mm 15-40 mm +/- 5%
• 10886705032693: MITEK TIGHT-N Tendon Docking Anchor Cannulated Reamer LARGE 8.5 mm 15-40 mm +/- 5%
• 10886705032686: MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor LARGE 8.5mm
• 10886705032679: MITEK TIGHT-N Tendon Docking Anchor Self Piloting Reamer MEDIUM 7.0 mm 15-40 mm +/- 5%
• 10886705032662: MITEK TIGHT-N Tendon Docking Anchor Cannulated Reamer MEDIUM 7.0 mm 15-40 mm +/- 5%
• 10886705032655: MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor MEDIUM 7.0mm
• 10886705032624: MITEK TIGHT-N Tendon Docking Anchor Self Piloting Reamer SMALL 5.5 mm 15-40 mm +/- 5%
• 10886705032617: MITEK TIGHT-N Tendon Docking Anchor Cannulated Reamer SMALL 5.5 mm 15-40 mm +/- 5%
• 10886705032600: MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor SMALL 5.5mm