V-LoX Knotless DEX 11263

GUDID M685112630

5.5 x 15 V-LoX Knotless DEX Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M685112630
• NIH Device Record Key: b72a00f9-270e-47d4-bbd9-ee9eccfb13c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-LoX Knotless DEX
• Version Model Number: 11263
• Catalog Number: 11263
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• 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: 941-755-7965
• Email: CustomerService@ParcusMedical.com

Device Dimensions

• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M685112630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170327

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: 2019-10-31
• Device Publish Date: 2019-10-23

On-Brand Devices [V-LoX Knotless DEX]

• M685112630: 5.5 x 15 V-LoX Knotless DEX Suture Anchor
• M685112620: 4.75 x 15 V-LoX Knotless DEX Suture Anchor