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
04048844758219EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758233EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758271EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
10603295552680ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555001ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555018ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555025ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555032ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555049ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555056ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555544ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12