FDA.reportPublic FDA data

VariTrax Sternal Template

Primary DI
00850049938075
Brand
VariTrax Sternal Template
Company
CircumFix Solutions, Inc.
Model
CFTK-TEMP
Device description
VariTrax Sternal Template
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049938075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049938075008500499380758500499380750850049938075

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
00850049938037VariTrax Sternal CircumFixator SetCFSK-01662024-05-01
00850049938044VariTrax Sternal CircumFixator SetCFSK-01782024-05-01
00850049938051VariTrax Sternal CircumFixator SetCFSK-01862024-05-01
00850049938068VariTrax Single BandCFSB-001S2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
00885556841532XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841549XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841556XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841563XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841570XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841587XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841594XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841600XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841655XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841662XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841679XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841686XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841693XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841709XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841716XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841723XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841730XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02