FDA.reportPublic FDA data

Traufix osteosynthesis, osteotomy, and arthrodesis devices

Primary DI
07506495312862
Brand
Traufix osteosynthesis, osteotomy, and arthrodesis devices
Company
Fixier, S.A. de C.V.
Model
148.03S
Catalog number
148.03S
Device description
ALP titanium distal radius plate LIONTER Small 3 holes right
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K201510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201510000Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.2022-02-18HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506495312862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506495312862075064953128627506495312862

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+524196881191internationalsales@fixier.com.mx

Regulatory Flags#

DUNS number
951561048
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
07506494214792Traufix osteosynthesis, osteotomy, and arthrodesis devices150.04150.042022-09-21
07506494214808Traufix osteosynthesis, osteotomy, and arthrodesis devices150.06150.062022-09-21
07506494214815Traufix osteosynthesis, osteotomy, and arthrodesis devices150.08150.082022-09-21
07506494214822Traufix osteosynthesis, osteotomy, and arthrodesis devices150.10150.102022-09-21
07506494214839Traufix osteosynthesis, osteotomy, and arthrodesis devices150.12150.122022-09-21
07506494214846Traufix osteosynthesis, osteotomy, and arthrodesis devices150.14150.142022-09-21
07506494214853Traufix osteosynthesis, osteotomy, and arthrodesis devices151.04151.042022-09-21
07506494214860Traufix osteosynthesis, osteotomy, and arthrodesis devices151.06151.062022-09-21
07506494214877Traufix osteosynthesis, osteotomy, and arthrodesis devices151.08151.082022-09-21
07506494214884Traufix osteosynthesis, osteotomy, and arthrodesis devices151.10151.102022-09-21
07506494214891Traufix osteosynthesis, osteotomy, and arthrodesis devices151.12151.122022-09-21
07506494214907Traufix osteosynthesis, osteotomy, and arthrodesis devices151.14151.142022-09-21
07506494214914Traufix osteosynthesis, osteotomy, and arthrodesis devices152.04152.042022-09-21
07506494214921Traufix osteosynthesis, osteotomy, and arthrodesis devices152.06152.062022-09-21
07506494214938Traufix osteosynthesis, osteotomy, and arthrodesis devices152.08152.082022-09-21
07506494214945Traufix osteosynthesis, osteotomy, and arthrodesis devices152.10152.102022-09-21
07506494214952Traufix osteosynthesis, osteotomy, and arthrodesis devices152.12152.122022-09-21
07506494214969Traufix osteosynthesis, osteotomy, and arthrodesis devices152.14152.142022-09-21
07506494214976Traufix osteosynthesis, osteotomy, and arthrodesis devices153.04153.042022-09-21
07506494214983Traufix osteosynthesis, osteotomy, and arthrodesis devices153.06153.062022-09-21

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