FDA.reportPublic FDA data

FuzeFix Chamfered Screws

Primary DI
00840124513884
Brand
FuzeFix Chamfered Screws
Company
FUSION ORTHOPEDICS, LLC
Model
TN-CS-8500
Catalog number
TN-CS-8500
Device description
Tunneling Tool
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QBOInstruments Designed For Press-Fit Osteochondral Implants

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170038000FuzeFix Screw SystemFusion Orthopedics, LLC2017-08-07HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124513884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124513884008401245138848401245138840840124513884

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-reduction toolA hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128461495CARTIHEAL AGILI-C Disposable Toolset 7.5T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461501CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461518CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
00840124520493FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2025-05-16
00840124514195PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124514201FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124512825PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512832PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512849PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512856PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512863PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124513853FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346938Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE Swami Medical, LLCQBO2024-08-22
07290019087199Agili-C Surgical Toolset Full Sterilization TrayCARTIHEAL (2009) LTDQBO2023-12-01
07290019087045Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087052Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087069Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087076Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087083Agili-C Sterilization CaseCARTIHEAL (2009) LTDQBO2022-10-04
07290019087090Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087106Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087113Agili-C Quick Connect Handle CARTIHEAL (2009) LTDQBO2022-10-04
07290019087120Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087137Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087144Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087151Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
10603295490531C-STEMDEPUY (IRELAND)QBO2022-09-22