FDA.reportPublic FDA data

FITBONE®

Primary DI
04260170143679
Brand
FITBONE®
Company
WITTENSTEIN intens GmbH
Model
CS 120V -A
Catalog number
60001644
Device description
Control Set for activation of intramedullary lengthening nail
Published
2021-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203399000FITBONE(R) TAAWittenstein Intens GmbH2021-02-17HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260170143679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260170143679042601701436794260170143679

GMDN Terms#

Term, Definition table
TermDefinition
Distraction plate/rod adjustment remote controlA portable, hand-held, electrically-powered device intended to be used to noninvasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail) to achieve the correct length; it may be used intraoperatively to test the functionality of the plate/rod. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4979314930info@wittenstein-intens.com

Regulatory Flags#

DUNS number
315887799
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260170143549FITBONE®DUMM TAA0960-F-220600018542021-04-17
04260170143556FITBONE®DUMM TAA0960-T-220600018552021-04-17
04260170143600FITBONE®RCS 120V -A600018712021-04-17
04260170143624FITBONE®CEl 120V60001645-00-02021-04-17
04260170143655FITBONE®DUMM TAA0940-F-200600019252021-04-17
04260170143662FITBONE®DUMM TAA0940-T-200600019272021-04-17
04260170144317FITBONE®Receiver600017802021-04-17
04260170140555FITBONE®DUMM TAA1160-T-225600008322017-12-12
04260170140562FITBONE®DUMM TAA1180-F-245600008222017-12-12
04260170140579FITBONE®DUMM TAA1140-F-205600012482017-12-12
04260170140586FITBONE®DUMM TAA1140-T-205600012442017-12-12
04260170140593FITBONE®DUMM TAA1160-F-225600011392017-12-12
04260170140609FITBONE®DUMM TAA1180-T-245600014952017-12-12
04260170140616FITBONE®DUMM TAA1380-F-245600016232017-12-12
04260170141651FITBONE®Transmitter600011492017-12-22
04260170143617FITBONE®CEl 115V600016452017-12-22
04260170143723FITBONE®CS 115V -A600016442017-12-22
04260170144003FITBONE®Receiver60001615-00-02017-12-22
04260170142375FITBONE®TAA0960-F-220600017642021-04-17
04260170142399FITBONE®TAA0960-T-220600018562021-04-17

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Primary DI, Brand, Company table
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