AIRLOCK Centrolock XMS01030

GUDID 03700879511757

Centrolock impactor

NOVASTEP

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03700879511757
• NIH Device Record Key: 04a8fc80-4acc-4084-bbfb-20323e35368a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRLOCK Centrolock
• Version Model Number: XMS01030
• Catalog Number: XMS01030
• 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	03700879511757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192356

FDA Product Code

• HRS: Plate, Fixation, Bone
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

[03700879511757]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-10
• Device Publish Date: 2020-01-02

On-Brand Devices [AIRLOCK Centrolock]

• 03700879512532: Centrolock implant trial holder
• 03700879512525: Centrolock Lid
• 03700879512518: Centrolock Tray
• 03700879512501: Centrolock temporary fixation pin - Single use
• 03700879512464: Centrolock K-wires holder
• 03700879512457: Centrolock countersink
• 03700879512440: Centrolock depth gauge
• 03700879512341: Centrolock countersink Single use
• 03700879512334: Centrolock temporary fixation pin
• 03700879512327: CENTROLOCK cortical screw Ø2 length 24
• 03700879512310: Airlock Centrolock Locking screw Ø2,5 length 26
• 03700879512303: Airlock Centrolock Locking screw Ø2,5 length 24
• 03700879512044: Centrolock drill bit Ø1.8 Single use
• 03700879512037: Centrolock drill bit Ø1.5 Single use
• 03700879512020: CENTROLOCK cortical screw Ø2 length 22
• 03700879512013: CENTROLOCK cortical screw Ø2 length 20
• 03700879512006: CENTROLOCK cortical screw Ø2 length 18
• 03700879511993: CENTROLOCK cortical screw Ø2 length 16
• 03700879511986: CENTROLOCK cortical screw Ø2 length 14
• 03700879511979: CENTROLOCK cortical screw Ø2 length 12
• 03700879511962: Airlock Centrolock Locking screw Ø2,5 length 22
• 03700879511955: Airlock Centrolock Locking screw Ø2,5 length 20
• 03700879511948: Airlock Centrolock Locking screw Ø2,5 length 18
• 03700879511931: Airlock Centrolock Locking screw Ø2,5 length 16
• 03700879511924: Airlock Centrolock Locking screw Ø2,5 length 14
• 03700879511917: Airlock Centrolock Locking screw Ø2,5 length 12
• 03700879511900: Airlock Centrolock Locking screw Ø2,5 length 10
• 03700879511894: Airlock Centrolock Locking screw Ø2,5 length 8
• 03700879511887: CENTROLOCK implant - Right step 6mm
• 03700879511870: CENTROLOCK implant - Right step 4mm
• 03700879511863: CENTROLOCK implant - Right step 2mm
• 03700879511856: CENTROLOCK implant - Left step 6mm
• 03700879511849: CENTROLOCK implant - Left step 4mm
• 03700879511832: CENTROLOCK implant - Left step 2mm
• 03700879511825: Centrolock trial implant - Right step 6mm
• 03700879511818: Centrolock trial implant - Right step 4mm
• 03700879511801: Centrolock trial implant - Right step 2mm
• 03700879511795: Centrolock trial implant - Left step 6mm
• 03700879511788: Centrolock trial implant - Left step 4mm
• 03700879511771: Centrolock trial implant - Left step 2mm
• 03700879511757: Centrolock impactor
• 03700879511740: Centrolock screwdriver tip T7
• 03700879511733: Centrolock drill bit Ø1.8
• 03700879511726: Centrolock drill bit Ø1.5
• 03700879511719: Centrolock drill guide - screw Ø2,5
• 03700879511702: Centrolock drill guide - screw Ø2
• 03700879511696: Centrolock targeting / compressing guide
• 03700879511689: Centrolock cannulated reamer
• 03700879511672: Centrolock elevator
• 03700879511665: Centrolock cutting guide