FDA.reportPublic FDA data

FibFix

Primary DI
00840124517776
Brand
FibFix
Company
FUSION ORTHOPEDICS, LLC
Model
TN-FN-8000-S
Catalog number
TN-FN-8000-S
Device description
Tissue Protector (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

Product Codes#

Code, Name table
CodeName
QACScrew Sleeve Bone Fixation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QACScrew Sleeve Bone Fixation DeviceOrthopedic2

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
00840124517776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124517776008401245177768401245177760840124517776

GMDN Terms#

Term, Definition table
TermDefinition
Bone screw fixation sleeveAn implantable tube-like sleeve intended to provide a secure fixing for a bone screw (e.g. orthopaedic, spinal) which has lost purchase due to screw loosening, back out, or breakage. It is inserted into the screw hole so that when a screw is inserted, a mechanical wedge is created as it is tightened. The sleeve is made of a non-bioabsorbable polymer and sleeve size is adjusted/configured intraoperatively. Disposable devices associated with implantation may be supplied with the sleeve.

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
00840124516762FibFixFUSION ORTHOPEDICS, LLCQAC2026-04-09
00850069061616Metalogix RevolutionFUSION ORTHOPEDICS, LLCQAC2025-12-09
00850069061647Metalogix RevolutionFUSION ORTHOPEDICS, LLCQAC2025-12-09
00850069061661Metalogix RevolutionFUSION ORTHOPEDICS, LLCQAC2025-12-09
00840124518452FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518469FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518476FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518483FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518490FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518506FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124518513FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124519992PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520004PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520011PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520158PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520165PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520172PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124520219PolyLock MidfootFUSION ORTHOPEDICS, LLCQAC2025-05-16
00840124519596PolyLockFUSION ORTHOPEDICS, LLCQAC2025-05-15
00840124519626PolyLockFUSION ORTHOPEDICS, LLCQAC2025-05-15
00840124519725PolyLockFUSION ORTHOPEDICS, LLCQAC2025-05-15
00840124519756PolyLockFUSION ORTHOPEDICS, LLCQAC2025-05-15
00840124519770PolyLockFUSION ORTHOPEDICS, LLCQAC2025-05-15
00840124519015FuzeFix Max FTFUSION ORTHOPEDICS, LLCQAC2025-05-14
00840124519022FuzeFix Max FTFUSION ORTHOPEDICS, LLCQAC2025-05-14
00840124519039FuzeFix Max FTFUSION ORTHOPEDICS, LLCQAC2025-05-14
00840124519213IntraLockFUSION ORTHOPEDICS, LLCQAC2025-05-14
00840124518773FuzeFix MiniFUSION ORTHOPEDICS, LLCQAC2025-05-13
00840124518780FuzeFix MiniFUSION ORTHOPEDICS, LLCQAC2025-05-13
00840124518797FuzeFix MiniFUSION ORTHOPEDICS, LLCQAC2025-05-13