V-LoX3

Basic Information

• Brand Name: V-LoX3
• Primary DI: M68510284T1
• Version / Model: 10284T
• Catalog Number: 10284T
• Company Name: PARCUS MEDICAL LLC
• Labeler DUNS: 859961950
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 5
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: c0248207-280b-4f50-a900-ff1004886301

Device Description

5.5mm V-LoX3 Titanium Suture Anchor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68510284T1	HIBCC
Unit of Use	M68510284T0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K090075	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.5	Millimeter