Stratis

GUDID 10884521513730

ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin

Covidien LP

Knee arthroplasty force sensor balance kit

• Primary Device ID: 10884521513730
• NIH Device Record Key: 92ee1e9c-7bce-49d3-9cdf-03c636b74586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratis
• Version Model Number: 2520SS
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521513730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041749

FDA Product Code

• HWC: Screw, fixation, bone

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: 2025-06-13
• Device Publish Date: 2015-10-22

On-Brand Devices [Stratis]

• 10884521513853: Retractable Switching Stick
• 10884521513839: Drill Tipped Guide Wire
• 10884521513822: Cannulated Acorn Drill Bit
• 10884521513815: Cannulated Acorn Drill Bit
• 10884521513808: Cannulated Acorn Drill Bit
• 10884521513792: Cannulated Drill Bit
• 10884521513785: Cannulated Drill Bit
• 10884521513778: Cannulated Drill Bit
• 10884521513693: ACL Reconstruction Graft Conditioning/Sizng Block
• 10884521513686: Transverse Drill
• 10884521513679: ACL System Sterilization Tray
• 10884521513648: Transverse Drill Sleeve
• 10884521513624: Drill Guide Handle Locking Nut
• 10884521513617: Transverse Drill Guide
• 10884521513570: Fixation Pin Inserter
• 10884521513549: ACL Femoral Reconstruction System Kit
• 10884521513754: ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin
• 10884521513730: ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin
• 10884521513716: ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin