FDA.reportPublic FDA data

FuzeFix Max FT

Primary DI
00840124524750
Brand
FuzeFix Max FT
Company
FUSION ORTHOPEDICS, LLC
Model
TN-CS-7950-S
Catalog number
TN-CS-7950-S
Device description
Chamfered Screw Jig Right (Sterile)
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
NNOJig, Piston Cutting, Ent, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNOJig, Piston Cutting, Ent, Non-SterileEar, Nose, Throat1

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
00840124524750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124524750008401245247508401245247500840124524750

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

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

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
00840124524743FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-11-03
00840124521681FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-09-17
00840124521698FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-09-17
00840124521025PolyLock MidfootFUSION ORTHOPEDICS, LLCNNO2025-06-24
00840124521032PolyLock MidfootFUSION ORTHOPEDICS, LLCNNO2025-06-24
09120034308000Drill BlockI.T.S. GmbHNNO2018-11-13
09120034308017Drill BlockI.T.S. GmbHNNO2018-11-13
09120034309854Drill BlockI.T.S. GmbHNNO2018-11-13
09120034309861Drill BlockI.T.S. GmbHNNO2018-11-13
09120069810950Drill BlockI.T.S. GmbHNNO2018-11-13
09120034308550JigI.T.S. GmbHNNO2018-11-06
09120034308710JigI.T.S. GmbHNNO2018-11-06
09120047297056JigI.T.S. GmbHNNO2018-11-06
09120047297063JigI.T.S. GmbHNNO2018-11-06
09120047297148JigI.T.S. GmbHNNO2018-11-06
09120047297209JigI.T.S. GmbHNNO2018-11-06
09120047306093JigI.T.S. GmbHNNO2018-11-06
09120047306109JigI.T.S. GmbHNNO2018-11-06
09120047308264JigI.T.S. GmbHNNO2018-11-06
09120069811636JigI.T.S. GmbHNNO2018-11-06
09120069812794JigI.T.S. GmbHNNO2018-11-06
00681490038416N/AMEDTRONIC XOMED, INC.NNO2017-09-10