FDA.reportPublic FDA data

ORTHOFIX

Primary DI
18052469476864
Brand
ORTHOFIX
Company
ORTHOFIX SRL
Model
1
Catalog number
70090001
Device description
FITBONE ANTEGRADE FEMUR INSTRUMENT TRAY BASE
Published
2024-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052469476864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805246947686418052469476864

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
Premarket exempt
true
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

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00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
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00840456214114JMUJMU DENTAL, INCFSM2026-06-23
00840456214121JMUJMU DENTAL, INCFSM2026-06-23
00840456215098JMUJMU DENTAL, INCFSM2026-06-23
00840456215111JMUJMU DENTAL, INCFSM2026-06-23
00840456215128JMUJMU DENTAL, INCFSM2026-06-23
00840456217580JMUJMU DENTAL, INCFSM2026-06-23