FDA.reportPublic FDA data

FibFix

Primary DI
00840124521254
Brand
FibFix
Company
FUSION ORTHOPEDICS, LLC
Model
FN-TH-1000-S
Catalog number
FN-TH-1000-S
Device description
End Cap Kit 0mm (Sterile)
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDTCap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDTCap, BoneOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252961000Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124521254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521254008401245212548401245212540840124521254

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail implantable capA small, implantable, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. Commonly known as an end-cap, it is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation 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
00840124516427FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516434FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516441FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516458FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516465FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516472FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124521070FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124521094FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124517431FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517448FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517455FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517462FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517479FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517486FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124521285Metalogix RevolutionFUSION ORTHOPEDICS, LLCJDT2025-07-23
04026575209644LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20
04026575209651LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20
04026575209668LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20
04026575209675LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20