FITBONE® 60002062

GUDID 04260170143570

WITTENSTEIN intens GmbH

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 ID04260170143570
NIH Device Record Key91b19e9d-a807-4d58-b684-605171199705
Commercial Distribution StatusIn Commercial Distribution
Brand NameFITBONE®
Version Model NumberME Tray TAA09/11 loan
Catalog Number60002062
Company DUNS315887799
Company NameWITTENSTEIN intens GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com
Phone+4979314930
Emailinfo@wittenstein-intens.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104260170143570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


[04260170143570]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [FITBONE®]

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

Trademark Results [FITBONE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FITBONE
FITBONE
79050501 3572845 Live/Registered
Wittenstein, Manfred
2008-01-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.