TREND II Spinal Fixation System- STEP Series 1600-5506

GUDID 04712832360318

Smooth Rod, D 5.50 x L 60 mm

Paonan Biotech Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	04712832360318
NIH Device Record Key	f6d17c38-ea68-4636-9a74-8e1421b60058
Commercial Distribution Status	In Commercial Distribution
Brand Name	TREND II Spinal Fixation System- STEP Series
Version Model Number	1600-5506
Catalog Number	1600-5506
Company DUNS	657397790
Company Name	Paonan Biotech Co.,Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter
Length	60 Millimeter
Outer Diameter	5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712832360318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180226

FDA Product Code

NKB	Thoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

[04712832360318]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-21
Device Publish Date	2023-09-13

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

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

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