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

GUDID 07290115934816

PREMIA SPINE LTD

Spinal guidewire
Primary Device ID07290115934816
NIH Device Record Key6c7d4596-d3bc-4cec-baa7-8b9c32274956
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA
Version Model Number87302
Company DUNS649220779
Company NamePREMIA SPINE LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115934816 [Primary]

FDA Product Code

QWKProsthesis, Posterior Spinal Elements

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


[07290115934816]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-09-17
Device Publish Date2024-09-05

Devices Manufactured by PREMIA SPINE LTD

07290014381223 - SST 316 LVM, L=470, Ø1.5 over the K-Wire2025-09-17
07290115934816 - K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA2025-09-17
07290115934816 - K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA2025-09-17
07290014381148 - SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill2025-09-16
07290014381155 - SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique2025-09-16
07290014381162 - SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire2025-09-16
07290014381186 - SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked)2025-09-16
07290014381193 - SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-Wire2025-09-16
07290014381209 - SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire2025-09-16

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.