Vector

GUDID 00810005666756

Structurally encoded implant 16mm long, 4.0mm diameter. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00810005666756
• NIH Device Record Key: 896e24ea-4d42-401b-aa08-dbb4e943f7a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vector
• Version Model Number: HAM-16-40
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• 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: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005666756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183055

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2019-11-30

On-Brand Devices [Vector]

• 00810005666763: Structurally encoded implant 17mm long, 4.0mm diameter. The Vector Hammertoe Correction System
• 00810005666756: Structurally encoded implant 16mm long, 4.0mm diameter. The Vector Hammertoe Correction System
• 00810005666749: Structurally encoded implant 15mm long, 4.0mm diameter. The Vector Hammertoe Correction System
• 00810005666732: Structurally encoded implant 15mm long, 3.5mm diameter. The Vector Hammertoe Correction System
• 00810005666725: Structurally encoded implant 14mm long, 3.5mm diameter. The Vector Hammertoe Correction System
• 00810005666718: Structurally encoded implant 13mm long, 3.5mm diameter. The Vector Hammertoe Correction System
• 00810005666787: Surgical case lid for instrument case. The Vector Hammertoe Correction System is indicated for
• 00810005666770: Inserter for implants 3.5 - 4.0mm diameter instrument. The Vector Hammertoe Correction System i
• 00810005666602: Implant Sizer, general surgical tool. The Vector Hammertoe Correction System is indicated for t
• 00810005666596: Surgical case for holding instruments. The Vector Hammertoe Correction System is indicated for
• 00810005666589: Drill 4.0mm diameter cannulated instrument. The Vector Hammertoe Correction System is indicated
• 00810005666572: Drill 3.5mm diameter cannulated instrument. The Vector Hammertoe Correction System is indicated
• 00810005666565: Cannulated Tap 4.0mm diameter instrument. The Vector Hammertoe Correction System is indicated f
• 00810005666558: Cannulated Tap 3.5mm Diameter instrument. The Vector Hammertoe Correction System is indicated f
• 00810005666541: 1.1mm K-wire, Instrument. The Vector Hammertoe Correction System is indicated for the fixation
• 00810005668446: Drill 4.5mm diameter cannulated instrument. The Vector Hammertoe Correction System is indicated
• 00810005669290: 17mm long, 4.0mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005669283: 16mm long, 4.0mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005669276: 15mm long, 4.0mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005669269: 15mm long, 3.5mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005669252: 14mm long, 3.5mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005669245: 13mm long, 3.5mm diameter encoded Hammertoe Implant (Steam). The Vector Hammertoe Correction Sy
• 00810005667791: 13mm long, 3.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660990: 17mm long, 4.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660983: 16mm long, 4.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660976: 15mm long, 4.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660969: 15mm long, 3.5mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660952: 14mm long, 3.5mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660945: 13mm long, 3.5mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660938: 15mm long, 3.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005660921: 14mm long, 3.0mm diameter Cannulated Hammertoe Implant. The Vector Hammertoe Correction System
• 00810005667883: Double Trocar K-wire, Instrument. The Vector Hammertoe Correction System is indicated for the f
• 00810005668972: Inserter for implants 3.0mm diameter instrument. The Vector Hammertoe Correction System is indi
• 00810005668965: Cannulated Tap 3.0mm diameter instrument. The Vector Hammertoe Correction System is indicated f
• 00810005668477: 12mm long, 3.0mm diameter Cannulated Hammertoe Implant (Steam). The Vector Hammertoe Correction
• 00810005667579: Drill 3.0mm diameter cannulated instrument. The Vector Hammertoe Correction System is indicated