FDA.reportPublic FDA data

K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA

Primary DI
07290115934816
Brand
K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA
Company
PREMIA SPINE LTD
Model
87302
Published
2024-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWKProsthesis, Posterior Spinal Elements

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWKProsthesis, Posterior Spinal ElementsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934816072901159348167290115934816

GMDN Terms#

Term, Definition table
TermDefinition
Spinal guidewireA thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115935837MIS Tower Guide86261N2026-06-01
07290115935349TOPS 2 - 21 S889442026-07-09
07290115935356TOPS 2 - 21 M889432026-07-09
07290115935363TOPS 2 - 21 L889422026-07-09
07290115935370TOPS 2 - 30 S889472026-07-09
07290115935387TOPS 2 - 30 M889462026-07-09
07290115935394TOPS 2 - 30 L889452026-07-09
07290115935400TOPS 2 - 38 S889502026-07-09
07290115935417TOPS 2 - 38 M889492026-07-09
07290115935424TOPS 2 - 38 L889482026-07-09
07290115935783TOPS 2 Inserter888932026-07-09
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01
07290115935646Cannulated Screwdriver External sleeve Short882662026-06-01
07290115935653Cannulated Screwdriver Handle Assy XL872452026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XL871542026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935349TOPS 2 - 21 SPREMIA SPINE LTDQWK2026-07-09
07290115935356TOPS 2 - 21 MPREMIA SPINE LTDQWK2026-07-09
07290115935363TOPS 2 - 21 LPREMIA SPINE LTDQWK2026-07-09
07290115935370TOPS 2 - 30 SPREMIA SPINE LTDQWK2026-07-09
07290115935387TOPS 2 - 30 MPREMIA SPINE LTDQWK2026-07-09
07290115935394TOPS 2 - 30 LPREMIA SPINE LTDQWK2026-07-09
07290115935400TOPS 2 - 38 SPREMIA SPINE LTDQWK2026-07-09
07290115935417TOPS 2 - 38 MPREMIA SPINE LTDQWK2026-07-09
07290115935424TOPS 2 - 38 LPREMIA SPINE LTDQWK2026-07-09
07290115935783TOPS 2 InserterPREMIA SPINE LTDQWK2026-07-09
07290115932751Alignment Gauge MediumPREMIA SPINE LTDQWK2026-06-01
07290115932898Cannulated Screwdriver External sleevePREMIA SPINE LTDQWK2026-06-01
07290115935622Cannulated Screwdriver Inner Shaft ShortPREMIA SPINE LTDQWK2026-06-01
07290115935639Cannulated Screwdriver Handle Assy ShortPREMIA SPINE LTDQWK2026-06-01
07290115935646Cannulated Screwdriver External sleeve ShortPREMIA SPINE LTDQWK2026-06-01
07290115935653Cannulated Screwdriver Handle Assy XLPREMIA SPINE LTDQWK2026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XLPREMIA SPINE LTDQWK2026-06-01
07290115935837MIS Tower GuidePREMIA SPINE LTDQWK2026-06-01
07290115935615Counter Torque STPREMIA SPINE LTDQWK2026-05-25
07290014381179K-Wire, Blunt Sharp Tip, L=352, Ø1.7mm XL Shidi-TecPREMIA SPINE LTDQWK2024-09-05
07290115934946K-Wire, CoCr, Blunt Sharp Tip, L=457, Ø1.7mm XL DKWAPREMIA SPINE LTDQWK2024-09-05
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power DrillPREMIA SPINE LTDQWK2024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechniquePREMIA SPINE LTDQWK2024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290014381186SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked)PREMIA SPINE LTDQWK2024-09-05
07290014381193SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290014381209SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934564K-Wire, Blunt Sharp Tip, L=230, Ø1.7mm Shidi-Tec 230PREMIA SPINE LTDQWK2024-09-05
07290115934571K-Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05