V-LoX3 10358T

GUDID M68510358T0

6.5mm V-LoX3 Titanium Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M68510358T0
• NIH Device Record Key: 955268b0-235f-4290-8f57-f0b1ee5f592c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-LoX3
• Version Model Number: 10358T
• Catalog Number: 10358T
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• 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: 941-755-7965
• Email: CustomerService@ParcusMedical.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68510358T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090075

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: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [V-LoX3]

• M68510325T0: 6.5mm V-LoX3 PEEK CF Suture Anchor
• M68510324T0: 5.5mm V-LoX3 PEEK CF Suture Anchor
• M68510358T0: 6.5mm V-LoX3 Titanium Suture Anchor
• M68510284T0: 5.5mm V-LoX3 Titanium Suture Anchor