FDA.reportPublic FDA data

FITBONE®

Primary DI
04260170140944
Brand
FITBONE®
Company
WITTENSTEIN intens GmbH
Model
TUBE T13/12-S
Catalog number
60001045
Device description
Tube T13/12-S
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
04260170140944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260170140944042601701409444260170140944

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter12Millimeter
Outer Diameter13Millimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
03701037310649FLEX NAILFX SOLUTIONSHSB2021-10-26
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03701037310670FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310687FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310694FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310700FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310717FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310724FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310731FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310748FLEX NAILFX SOLUTIONSHSB2021-10-26