FDA.reportPublic FDA data

TOMOFIX

Primary DI
10886982074515
Brand
TOMOFIX
Company
Synthes GmbH
Model
03.120.069
Catalog number
03120069
Device description
TOMOFIX GUIDING BLOCK FOR MEDIAL DISTAL FEMUR PLATE-LT
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141796000DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEMSynthes (USA) Products, LLC2014-08-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819418721Direct MarkingGS10
10886982074515PrimaryGS10
H679031200690SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819418721076118194187217611819418721
1088698207451510886982074515

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block attachment toolA manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

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00815432024438DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024346DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024414DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024445DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024452DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024469DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024384DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-10
00815432025473MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025480MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025497MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
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00815432025510MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025541MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025572MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432026524MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026531MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026548MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026555MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026562MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04