FDA.reportPublic FDA data

SPARTAN

Primary DI
00840916160210
Brand
SPARTAN
Company
SPINAL ELEMENTS
Model
9152-5050
Device description
5.0 x 50 FACET SCREW CANNULATED
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916160210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916160210008409161602108409161602100840916160210

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916143084PIRANHACSVS-425-162021-01-09
00840916143091PIRANHACSVS-425-182021-01-09
00840916135119BLACK WIDOWTBS0452021-01-07
00840916135126BLACK WIDOWTBS0502021-01-07
00840916135133BLACK WIDOWTBS0552021-01-07
00840916103941DIAMOND6-1-302017-05-23
00840916103958DIAMOND6-1-322017-05-23
00840916103965DIAMOND6-1-342017-05-23
00840916103972DIAMOND6-2-362017-05-23
00840916103989DIAMOND6-2-392017-05-23
00840916103996DIAMOND6-2-422017-05-23
00840916104009DIAMOND6-2-452017-05-23
00840916104016DIAMOND6-2-482017-05-23
00840916104023DIAMOND6-2-512017-05-23
00840916104030DIAMOND6-3-532017-05-23
00840916104047DIAMOND6-2-542017-05-23
00840916104054DIAMOND6-3-562017-05-23
00840916104061DIAMOND6-3-592017-05-23
00840916104078DIAMOND6-3-622017-05-23
00840916104085DIAMOND6-3-652017-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800039819909FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819916FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819923FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819930FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819947FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819954FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819961FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819978FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819985FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819992FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820004FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820011FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820028FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820035FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820042FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820059FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820318FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820325FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820332FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820349FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039821391FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823739FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823746FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823753FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823760FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823777FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823784FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823791FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823807FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823814FasetDIOMEDICAL CO.,LTD.MRW2019-02-08