V-LoX 10353T

GUDID M68510353T0

4.5mm V-LoX Titanium Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M68510353T0
• NIH Device Record Key: e2b3a356-8a96-4b35-99a4-687a75843739
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-LoX
• Version Model Number: 10353T
• Catalog Number: 10353T
• 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: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68510353T0 [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-LoX]

• M685102641: 6.5mm V-LoX PEEK CF Suture Anchor with Needles
• M685102640: 6.5mm V-LoX PEEK CF Suture Anchor with Needles
• M685102631: 5.5mm V-LoX PEEK CF Suture Anchor with Needles
• M685102630: 5.5mm V-LoX PEEK CF Suture Anchor with Needles
• M68510254T0: 6.5mm V-LoX PEEK CF Suture Anchor
• M68510253T0: 5.5mm V-LoX PEEK CF Suture Anchor
• M685102530: 5.5mm V-LoX PEEK CF Suture Anchor
• M68510356T0: 5.5mm V-LoX Titanium Suture Anchor
• M68510353T0: 4.5mm V-LoX Titanium Suture Anchor
• M685102580: 6.5mm V-LoX Titanium Suture Anchor with Needles
• M685102570: 5.0mm V-LoX Titanium Suture Anchor with Needles
• M68510252T0: 6.5 mm V-LoX Titanium Suture Anchor
• M685102510: 5.0mm V-LoX Titanium Suture Anchor
• 00816342021029: 6.5mm V-lox Titanium Suture Anchor with Needles
• 00816342023849: 5.5mm V-lox PEEK CF Suture Anchor with Needles
• 00816342022224: 6.5mm V-lox Titanium Suture Anchor
• 00816342022217: 5.5mm V-lox Titanium Suture Anchor
• 00816342022200: 4.5mm V-lox Titanium Suture Anchor
• 00816342022187: 6.5mm V-lox PEEK CF Suture Anchor
• 00816342022170: 5.5mm V-lox PEEK CF Suture Anchor
• 00816342022156: 5.5mm V-lox Titanium Suture Anchor
• 00816342022149: 6.5mm V-lox Titanium Suture Anchor with Needles
• 00816342022132: 6.5mm V-lox PEEK CF Suture Anchor
• 00816342022125: 5.5mm V-LoX PEEK CF Suture Anchor
• 00816342022118: 6.5 mm V-lox Titanium Suture Anchor
• 00816342021067: 5.5mm V-lox Titanium Suture Anchor
• 00816342021012: 5.0mm V-lox Titanium Suture Anchor with Needles
• 00816342021005: 6.5mm V-lox PEEK CF Suture Anchor
• 00816342020992: 5.5mm V-LoX PEEK CF Suture Anchor
• 00816342020985: 6.5mm V-lox Titanium Suture Anchor
• 00816342020978: 5.0mm V-lox Titanium Suture Anchor