FDA.reportPublic FDA data

Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire

Primary DI
07290115934670
Brand
Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire
Company
PREMIA SPINE LTD
Model
87009
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150380000
K170061000
K231844000
P220002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150380000ProMIS Fixation SystemPremia Spine, Ltd.2015-07-17NKB
K170061000ProMIS™ Fixation SystemPremia Spine, Ltd.2017-02-02NKB
K231844000ProMIS™ Fixation SystemPremia Spine, Ltd.2023-07-07NKB
P220002000TOPS™ SystemPremia Spine, Ltd.2023-06-15QWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934670072901159346707290115934670

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
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
07290115935837MIS Tower Guide86261N2026-06-01
07290014381254ProMIS™ Fixation System875112026-05-25
07290014381261ProMIS™ Fixation System875122026-05-25
07290115935615Counter Torque ST83142N2026-05-25
07290115932553VersaLink Bender825842024-10-01
07290115935479Rod Bender862972024-10-01
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-Wire878512024-09-05
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA873022024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill874472024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique872092024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire872082024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWAPREMIA 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
07290115934588K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWAPREMIA SPINE LTDQWK2024-09-05
07290115934687Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934786K-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKWAPREMIA SPINE LTDQWK2024-09-05
07290115934854Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934939K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.DrillPREMIA SPINE LTDQWK2024-09-05
07290115934984K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.DrillPREMIA SPINE LTDQWK2024-09-05
07290115935042Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115935110K-Wire, Blunt Beveled Tip, L=335,Ø 1.7 mm KWAPREMIA SPINE LTDQWK2024-09-05
07290115931686Tap Ø 5.5 for Pendulum AdaptorPREMIA SPINE LTDQWK2024-09-03