TREND II Spinal Fixation System- STEP Series 1226-5530L

GUDID 04719878783491

MISS Reduction Multiaxial Cannulated Screw, D 5.50 x L 30 mm

Paonan Biotech Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04719878783491
• NIH Device Record Key: 888c0979-f97a-4bbf-833a-04df5a380902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TREND II Spinal Fixation System- STEP Series
• Version Model Number: 1226-5530L
• Catalog Number: 1226-5530L
• 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: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878783491 [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

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

[04719878783491]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-02
• Device Publish Date: 2024-01-25

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