Javelin

GUDID 00810005665667

3.00mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810005665667
• NIH Device Record Key: f0a54274-e6a3-47d6-82f4-21fd64514acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Javelin
• Version Model Number: TB-30-14N
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• 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: false
• 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

Device Dimensions

• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005665667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202657

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

[00810005665667]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [Javelin]

• 00810005665698: Plate 40mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation de
• 00810005665681: Plate 30mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation de
• 00810005665674: 3.00mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665667: 3.00mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665650: 3.00mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665643: 3.00mm dia 10mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665636: 3.00mm dia 8mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a singl
• 00810005665629: 3.00mm dia 6mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a singl
• 00810005665612: 2.40mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665605: 2.40mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665599: 2.40mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665582: 2.40mm dia 10mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a sing
• 00810005665575: 2.40mm dia 8mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a singl
• 00810005665568: 2.40mm dia 6mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a singl
• 00810005665551: 3.00mm dia 16mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665544: 3.00mm dia 14mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665537: 3.00mm dia 12mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665520: 3.00mm dia 10mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665421: 3.00mm dia 8mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005665414: 3.00mm dia 6mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005665407: 2.40mm dia 16mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665391: 2.40mm dia 14mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665384: 2.40mm dia 12mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665377: 2.40mm dia 10mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-u
• 00810005665360: 2.40mm dia 8mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005665353: 2.40mm dia 6mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005662864: Instrument: Screw Inserter. The Javelin Tailor’s Bunion Fixation System is a single-use bone
• 00810005662635: Instrument: Depth Gauge. The Javelin Tailor’s Bunion Fixation System is a single-use bone fix
• 00810005662628: Instrument: Broach. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation
• 00810005662611: Instrument: Targeting Jig Plate Inserter. The Javelin Tailor’s Bunion Fixation System is a si
• 00810005662604: Instrument: 40mm Targeting Jig Drill Guide. The Javelin Tailor’s Bunion Fixation System is a
• 00810005662598: Instrument: 30mm Targeting Jig Drill Guide. The Javelin Tailor’s Bunion Fixation System is a
• 00810005662581: Instrument: Drill for 3.0mm Screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005662574: Instrument: Drill for 2.4mm Screw. The Javelin Tailor’s Bunion Fixation System is a single-us
• 00810005660914: Instrument: AO Handle, Small. The Javelin Tailor’s Bunion Fixation System is a single-use bon
• 00810005660907: Instrument: Broach Extractor. The Javelin Tailor’s Bunion Fixation System is a single-use bon
• 00810005660891: Instrument: Plate Extractor. The Javelin Tailor’s Bunion Fixation System is a single-use bone
• 00810005660884: Instrument: Slotted Mallet. The Javelin Tailor’s Bunion Fixation System is a single-use bone
• 00810005667807: Javelin Screw Caddy Lid. The Javelin Tailor’s Bunion Fixation System is a single-use bone fix
• 00810005663977: Javelin Screw Caddy Body. The Javelin Tailor’s Bunion Fixation System is a single-use bone fi
• 00810005663960: Javelin Lid. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device
• 00810005663953: Javelin Case. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation devic