LYNC XRA01002

GUDID 03700879500522

Lync distal rasp

NOVASTEP

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03700879500522
• NIH Device Record Key: cece2009-2e7f-4861-a95e-ff8a578b2363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYNC
• Version Model Number: XRA01002
• Catalog Number: XRA01002
• Company DUNS: 264255288
• Company Name: NOVASTEP
• 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: false
• 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: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879500522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143049

FDA Product Code

• HTY: Pin, Fixation, Smooth
• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

[03700879500522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-26
• Device Publish Date: 2016-09-15

On-Brand Devices [LYNC]

• 03700879500898: Lync forceps
• 03700879500522: Lync distal rasp
• 03700879500515: Lync proximal rasp
• 03700879503042: Lync Drill Bit Ø2.3 single-use
• 03700879500645: Lync surfacing reamer
• 03700879500638: Lync Drill Bit Ø2.3
• 03700879500799: Lync Caddy
• 03700879509655: Lync DIP
• 03700879509648: Lync S10
• 03700879509631: Lync S0
• 03700879503578: Lync module
• 03700879500966: Lync implants module
• 03700879500454: Lync L10
• 03700879500447: Lync L0
• 03700879500430: Lync M10
• 03700879500423: Lync M0