FDA.reportPublic FDA data

FuzeFix Large

Primary DI
00840124518902
Brand
FuzeFix Large
Company
FUSION ORTHOPEDICS, LLC
Model
TN-FX-7055
Catalog number
TN-FX-7055
Device description
5.5mm FX Drill Sleeve
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NJAAccessory, System, External Fixator, Containing Antimicrobial Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJAAccessory, System, External Fixator, Containing Antimicrobial AgentOrthopedic2

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
00840124518902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124518902008401245189028401245189020840124518902

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, single-useA sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use 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
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521797PolyLock MidfootTN-CA-2003TN-CA-20032025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14
00840124519244LapiLockTN-LL-5075TN-LL-50752025-05-14
00840124519251LapiLockTN-LL-5085TN-LL-50852025-05-14
00840124519268LapiLockTN-LL-5185TN-LL-51852025-05-14
00840124519275LapiLockTN-LL-5285TN-LL-52852025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124514133TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124514140TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124521551FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521568FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521575FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521582FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521636FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521643FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124518919FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518926FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518933FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519152IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519176IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518896FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-13
00840124507623PolyLock SmallBoneFUSION ORTHOPEDICS, LLCNJA2023-06-12