FDA.reportPublic FDA data

ORTHOFIX

Primary DI
18052469476680
Brand
ORTHOFIX
Company
ORTHOFIX SRL
Model
1
Catalog number
7001285
Device description
FITBONE TROCHANTERIC TRIAL NAIL L285MM D11MM
Published
2024-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233867000Fitbone TrochantericOrthofix Srl2024-06-18HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052469476680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805246947668018052469476680

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail trial, reusableA copy of a final orthopaedic bone nail designed to be introduced into the proximal and/or distal end of the intramedullary canal of a long bone (e.g., through the femoral head) to function as a reference for the subsequent introduction of the final bone nail, and typically also guide wire and/or bone screws. It is typically used in conjunction with appropriate holders/positioning devices (not included). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length285Millimeter
Outer Diameter11Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18053504361176TRUELOK SYSTEM154-115602018-04-28
18059015376654MINIRAL1M191-012026-05-04
18059015376661MINIRAL1M191-022026-05-04
18059015376678MINIRAL1M1912026-05-04
18059015376692PENNIG MINIFIXATOR1M444-012026-05-04
18059015376708PENNIG MINIFIXATOR1M444-022026-05-04
18059015376715PENNIG MINIFIXATOR1M4442026-05-04
18059015376784PENNIG DYNAMIC WRIST FIXATOR113761-012026-05-04
18059015376791PENNIG DYNAMIC WRIST FIXATOR113761-022026-05-04
18059015376807PENNIG DYNAMIC WRIST FIXATOR113761-032026-05-04
18059015376814PENNIG DYNAMIC WRIST FIXATOR1137612026-05-04
18054242515173Galaxy UNYCO System199-936732016-07-27
18054242515180Galaxy UNYCO System199-936702016-07-27
18052469476055ORTHOFIX MODULSYSTEM1M1462022-12-27
18052469476086ORTHOFIX MODULSYSTEM199-M1462022-12-27
18052469476406ORTHOFIX MODULSYSTEM199-M14602022-12-27
18053504369721ORTHOFIX GALAXY FIXATION SYSTEM1930402019-05-31
18053504369738ORTHOFIX GALAXY FIXATION SYSTEM1931402019-05-31
18059015375879TrueLok Elevate150-2590C2025-01-03
18059015375909TrueLok Elevate150-25052025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
03701037310649FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310656FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310663FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310670FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310687FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310694FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310700FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310717FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310724FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310731FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310748FLEX NAILFX SOLUTIONSHSB2021-10-26