FDA.reportPublic FDA data

SAMBA SCREW

Primary DI
18257200122141
Brand
SAMBA SCREW
Company
ORTHOFIX INC.
Model
11-1109-FD17
Device description
DRIVER BIT T-HANDLE
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200122141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720012214118257200122141

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterileA non-sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200068166PILLAR XL72-19092019-03-19
18257200081387CONSTRUX - PEEK VBR450217-000148-00102020-02-03
18257200131969PEMF - PHYSIO-STIM655302-000153022020-01-16
18257200131976PEMF - PHYSIO-STIM655303-000153032020-01-16
18257200131983PEMF - PHYSIO-STIM655313-000153132020-01-16
18257200131990PEMF - PHYSIO-STIM655314-00015314L2020-01-16
18257200132003PEMF - PHYSIO-STIM655314-01015314R2020-01-16
18257200132010PEMF - PHYSIO-STIM655315-000153152020-01-16
18257200022151FORZA87-1209SP2019-09-24
18257200022168FORZA87-1210SP2019-09-24
18257200022175FORZA87-1211SP2019-09-24
18257200022182FORZA87-1212SP2019-09-24
18257200022199FORZA87-1213SP2019-09-24
18257200022205FORZA87-1214SP2019-09-24
18257200022212FORZA87-1215SP2019-09-24
18257200022229FORZA87-1216SP2019-09-24
18257200022236FORZA87-1308SP2019-09-24
18257200022243FORZA87-1309SP2019-09-24
18257200022250FORZA87-1310SP2019-09-24
18257200022267FORZA87-1311SP2019-09-24

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Primary DI, Brand, Company table
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