FDA.reportPublic FDA data

VariTrax Sternal CircumFixator Set

Primary DI
00850049938037
Brand
VariTrax Sternal CircumFixator Set
Company
CircumFix Solutions, Inc.
Model
CFSK-0166
Device description
VariTrax Sternal CircumFixator Set, 166mm
Published
2024-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDQCerclage, Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232986000VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.2024-01-30JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049938037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049938037008500499380378500499380370850049938037

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057130264
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049938105VariTrax Sternal Circumfixator Sternal PlateCFSP-0186S2025-10-17
00850049938112VariTrax Sternal Circumfixator Sternal PlateCFSP-0178S2025-10-17
00850049938129VariTrax Sternal Circumfixator Sternal PlateCFSP-0166S2025-10-17
00850049938136VariTrax Sternal Circumfixator Sternal PlateCFSP-0154S2025-10-17
00850049938143VariTrax Sternal Circumfixator Sternal PlateCFSP-0142S2025-10-17
00850049938150VariTrax Sternal Circumfixator Sternal PlateCFSP-0130S2025-10-17
00850049938167VariTrax Sternal Circumfixator BandsCFMB-0012025-10-17
00850049938082VariTrax Instrument KitCFIK-INST2024-05-01
00850049938006VariTrax Sternal CircumFixator SetCFSK-01302024-05-01
00850049938013VariTrax Sternal CircumFixator SetCFSK-01422024-05-01
00850049938020VariTrax Sternal CircumFixator SetCFSK-01542024-05-01
00850049938044VariTrax Sternal CircumFixator SetCFSK-01782024-05-01
00850049938051VariTrax Sternal CircumFixator SetCFSK-01862024-05-01
00850049938068VariTrax Single BandCFSB-001S2024-05-01
00850049938075VariTrax Sternal TemplateCFTK-TEMP2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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