FDA.reportPublic FDA data

VariTrax Instrument Kit

Primary DI
00850049938082
Brand
VariTrax Instrument Kit
Company
CircumFix Solutions, Inc.
Model
CFIK-INST
Device description
VariTrax Instrument Kit
Published
2024-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTZInstrument, Cutting, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049938082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049938082008500499380828500499380820850049938082

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
057130264
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
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
00850049938075VariTrax Sternal TemplateCFTK-TEMP2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
00196449033454Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033461Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033591Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033676Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034192Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
B471293000100GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
10886982339492NASynthes GmbHHTZ2024-10-09
10887587077611NASynthes GmbHHTZ2024-08-21
07898506814107QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814114QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841677QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841691QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841707QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841714QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841752QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506848959QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849413QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849420QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814329QuinelatoSchobell Industrial LtdaHTZ2022-12-16