TREND II Spinal Fixation System- STEP Series 1600-5519C

GUDID 04719889595557

Curve Smooth Rod (MIS), D 5.50 x L 190 mm

Paonan Biotech Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID04719889595557
NIH Device Record Keyaf74ef39-00fa-4262-9824-7c25624c0345
Commercial Distribution StatusIn Commercial Distribution
Brand NameTREND II Spinal Fixation System- STEP Series
Version Model Number1600-5519C
Catalog Number1600-5519C
Company DUNS657397790
Company NamePaonan Biotech Co.,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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter
Outer Diameter5.5 Millimeter
Length190 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104719889595557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

[04719889595557]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-23
Device Publish Date2024-07-15

On-Brand Devices [TREND II Spinal Fixation System- STEP Series]

04719889593829Smooth Rod, D 5.50 x L 55 mm
04719889593812Smooth Rod, D 5.50 x L 45 mm
04719884695955Multiaxial Cannulated Screw, D 7.50 x L 50 mm
04719884695382Multiaxial Cannulated Screw, D 5.00 x L 45 mm
04719884695375Multiaxial Cannulated Screw, D 5.00 x L 40 mm
04712832360394Smooth Rod, D 5.50 x L 170 mm
04712832360387Smooth Rod, D 5.50 x L 150 mm
04712832360370Smooth Rod, D 5.50 x L 130 mm
04712832360363Smooth Rod, D 5.50 x L 110 mm
04712832360356Smooth Rod, D 5.50 x L 100 mm
04712832360349Smooth Rod, D 5.50 x L 90 mm
04712832360332Smooth Rod, D 5.50 x L 80 mm
04712832360325Smooth Rod, D 5.50 x L 70 mm
04712832360318Smooth Rod, D 5.50 x L 60 mm
04712832360301Smooth Rod, D 5.50 x L 50 mm
04712832360295Smooth Rod, D 5.50 x L 40 mm
04710281449561Multiaxial Cannulated Screw, D 7.50 x L 45 mm
04710281449554Multiaxial Cannulated Screw, D 7.50 x L 40 mm
04710281449516Multiaxial Cannulated Screw, D 6.50 x L 50 mm
04710281449509Multiaxial Cannulated Screw, D 6.50 x L 45 mm
04710281449493Multiaxial Cannulated Screw, D 6.50 x L 40 mm
04710281449486Multiaxial Cannulated Screw, D 6.50 x L 35 mm
04710281449455Multiaxial Cannulated Screw, D 5.50 x L 50 mm
04710281449448Multiaxial Cannulated Screw, D 5.50 x L 45 mm
04710281449431Multiaxial Cannulated Screw, D 5.50 x L 40 mm
04710281444931Torx Set Screw, H 5.00 x D 9.2 mm
04719889590774Curve Smooth Rod (MIS), D 5.50 x L 130 mm
04719889590750Curve Smooth Rod (MIS), D 5.50 x L 80 mm
04719889590743Curve Smooth Rod (MIS), D 5.50 x L 60 mm
04719889590736Curve Smooth Rod (MIS), D 5.50 x L 50 mm
04719889590729Curve Smooth Rod (MIS), D 5.50 x L 40 mm
04710281449639Curve Smooth Rod (MIS), D 5.50 x L 110 mm
04710281449622Curve Smooth Rod (MIS), D 5.50 x L 100 mm
04710281449578Curve Smooth Rod (MIS), D 5.50 x L 55 mm
04710281444924Curve Smooth Rod (MIS), D 5.50 x L 90 mm
04710281444900Curve Smooth Rod (MIS), D 5.50 x L 70 mm
04710281444870Curve Smooth Rod (MIS), D 5.50 x L 45 mm
04719878783910Multiaxial Cannulated Screw, D 6.50 x L 60 mm
04719878783903MISS Reduction Multiaxial Cannulated Screw, D 6.50 x L 55 mm
04719878783897MISS Reduction Multiaxial Cannulated Screw, D 6.50 x L 50 mm
04719878783880MISS Reduction Multiaxial Cannulated Screw, D 6.50 x L 45 mm
04719878783873MISS Reduction Multiaxial Cannulated Screw, D 6.50 x L 40 mm
04719878783866MISS Reduction Multiaxial Cannulated Screw, D 6.50 x L 35 mm
04719878783545MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 55 mm
04719878783538MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 50 mm
04719878783521MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 45 mm
04719878783514MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 40 mm
04719878783507MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 35 mm
04719878783491MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 30 mm
04719889595557Curve Smooth Rod (MIS), D 5.50 x L 190 mm
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