FDA.reportPublic FDA data

FITBONE®

Primary DI
04260170140579
Brand
FITBONE®
Company
WITTENSTEIN intens GmbH
Model
DUMM TAA1140-F-205
Catalog number
60001248
Device description
Dummy TAA1140-F-205
Published
2017-12-12
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
K163368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163368000FITBONE TAAWittenstein Intens GmbH2017-01-26HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260170140579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260170140579042601701405794260170140579

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail trialA cylindrical rod that simulates an orthopaedic bone nail designed to be placed into the proximal end of the intramedullary canal of a long bone (e.g., through the femoral head) to act as a decisive reference point for the subsequent drilling and insertion of guide wires/bone screws to secure the fracture(s); the dummy nail is then exchanged with the implant nail. An orthopaedic implant/trial implant holder is connected to the exposed end of the dummy nail whilst in situ and it is this alignment together with a connecting screw and an aiming arm which provides the surgeon with the correct calculated positions and angles for the final placement of the bone screws. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length205Millimeter
Outer Diameter11Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315887799
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
04260170143679FITBONE®CS 120V -A600016442021-04-17
04260170144317FITBONE®Receiver600017802021-04-17
04260170140555FITBONE®DUMM TAA1160-T-225600008322017-12-12
04260170140562FITBONE®DUMM TAA1180-F-245600008222017-12-12
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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