FDA.reportPublic FDA data

ORTHOFIX

Primary DI
18052469476802
Brand
ORTHOFIX
Company
ORTHOFIX SRL
Model
1
Catalog number
700336
Device description
M8 CONICAL MALLET ADAPTOR
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
GFJMallet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052469476802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805246947680218052469476802

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation hammering attachmentA surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter4Millimeter
Outer Diameter8Millimeter
Outer Diameter10Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71200TBS BASICSACME ENTERPRISE.GFJ2026-05-22
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05055445941093SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941109SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941116SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941123SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941130SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941147SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941154SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941161SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941178SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941185SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941192SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941208SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941215SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941222SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941239SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941260SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941277SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941284SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941291SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941307SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941314SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941321SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941338SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941345SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941352SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941369SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12