FITBONE® 60001967

GUDID 04260170144218

WITTENSTEIN intens GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04260170144218
• NIH Device Record Key: e428490d-215f-41d2-8f74-69ce4014dacf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITBONE®
• Version Model Number: Instrument Tray TAA09
• Catalog Number: 60001967
• Company DUNS: 315887799
• Company Name: WITTENSTEIN intens GmbH
• 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: false
• Serial Number: true
• 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: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com
• Phone: +4979314930
• Email: info@wittenstein-intens.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260170144218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203399

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

[04260170144218]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-10
• Device Publish Date: 2021-06-02

On-Brand Devices [FITBONE®]

• 04260170144034: Intramedullary lengthening nail
• 04260170144027: Intramedullary lengthening nail
• 04260170144003: Subcutaneous Energy Receiver
• 04260170143983: Intramedullary lengthening nail
• 04260170143969: Intramedullary lengthening nail
• 04260170143952: Intramedullary lengthening nail
• 04260170143945: Intramedullary lengthening nail
• 04260170143938: Intramedullary lengthening nail
• 04260170143723: Control Set for activation of intramedullary lengthening nail
• 04260170143617: Power Source for Transmitter - part of Control Set
• 04260170143518: Cone C13 retropatellar
• 04260170142641: Reamer D15.0 L200 L700 rounded
• 04260170142634: Reamer D14.0 L200 L700 rounded
• 04260170141651: Transcutaneous Energy Transmitter - part of Control Set
• 04260170141637: Locking screw D4.5 L80 long thread
• 04260170141620: Locking screw D4.5 L75 long thread
• 04260170141613: Locking screw D4.5 L70 long thread
• 04260170141606: Locking screw D4.5 L65 long thread
• 04260170141590: Locking screw D4.5 L60 long thread
• 04260170141583: Locking screw D4.5 L55 long thread
• 04260170141576: Locking screw D4.5 L50 long thread
• 04260170141569: Locking screw D4.5 L45 long thread
• 04260170141552: Locking screw D4.5 L40 long thread
• 04260170141545: Locking screw D4.5 L35 long thread
• 04260170141538: Locking screw D4.5 L30 long thread
• 04260170141521: Locking screw D4.5 L25 long thread
• 04260170141514: Locking screw D4.5 L20 long thread
• 04260170141507: Locking screw D4.5 L50 short thread
• 04260170141491: Locking screw D4.5 L45 short thread
• 04260170141484: Locking screw D4.5 L40 short thread
• 04260170141477: Locking screw D4.5 L35 short thread
• 04260170141460: Locking screw D4.5 L30 short thread
• 04260170141453: Locking screw D4.5 L25 short thread
• 04260170141446: Locking screw D4.5 L20 short thread
• 04260170141422: Drill guide block screws TAA11
• 04260170141415: GRID plate
• 04260170141408: Kirschner wire D3 L280
• 04260170141392: Clamp
• 04260170141385: Cone-Sinker CS12-11
• 04260170141378: Cone-Sinker CS15-13
• 04260170141361: Tube-Sinker TS11
• 04260170141354: Tube-Sinker TS12
• 04260170141347: Tube-Sinker TS13
• 04260170141330: Tube-Sinker TS14
• 04260170141323: Tube-Sinker TS15
• 04260170141316: Cone C11
• 04260170141309: Cone C12
• 04260170141293: Cone C13++
• 04260170141286: Cone C13+
• 04260170141279: Cone C13