KISSloc® 9V00-0100

GUDID M5289V0001000

KISSloc, Suture Construct

ARTHROSURFACE INCORPORATED

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: M5289V0001000
• NIH Device Record Key: af4a08e8-fa07-4377-b018-cfdfa51f0fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KISSloc®
• Version Model Number: 9V00-0100
• Catalog Number: 9V00-0100
• Company DUNS: 144666109
• Company Name: ARTHROSURFACE INCORPORATED
• 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: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5289V0001000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133835

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-09-15

On-Brand Devices [KISSloc®]

• M5289V0002000: KISSloc, Arrow, I K
• M5289V0001000: KISSloc, Suture Construct