Trend Ii Spinal Fixation System - Step Series

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K180226

by Paonan Biotech Co., Ltd.

Identity

Trade Name: TREND II Spinal Fixation System- STEP Series FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Multiaxial Cannulated Screw, D 5.50 x L 40 mm FDA UDI
Model / Reference: 1226-5540 FDA UDI
Description: Multiaxial Cannulated Screw, D 5.50 x L 40 mm FDA UDI

Identifiers

Catalog Number: 1226-5540 FDA UDI
Primary DI / UDI-DI: 04710281449431 FDA UDI
510(k) Number: K180226 FDA 510(k)FDA UDI
FDA Product Code: NKB FDA 510(k)FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 888.3070 FDA 510(k)
Regulation Number: 888.3070 FDA 510(k)FDA UDI
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI
Outer Diameter — 5.50 Millimeter FDA UDI

The Trend Ii Spinal Fixation System - Step Series is a spinal fixation system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. It is designed for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/ilac spine. The system is used for indications such as degenerative disc disease.

The Trend Ii Spinal Fixation System - Step Series is supplied with various components, including smooth rods and multiaxial cannulated screws, in different sizes. It has received FDA 510K authorization, with a decision date of 2018-07-25 and a k number of K180226. The system is manufactured by Paonan Biotech Co., Ltd.

Frequently asked questions

What is the TREND II Spinal Fixation System used for?

The TREND II Spinal Fixation System is used for indications such as degenerative disc disease, providing immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft.

What components are included in the TREND II Spinal Fixation System?

The system is supplied with various components, including smooth rods and multiaxial cannulated screws, in different sizes.

Is the TREND II Spinal Fixation System authorized by the FDA?

Yes, the TREND II Spinal Fixation System has received FDA 510K authorization, with a decision date of 2018-07-25 and a k number of K180226.

Who manufactures the TREND II Spinal Fixation System?

The TREND II Spinal Fixation System is manufactured by Paonan Biotech Co., Ltd.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TREND II Spinal Fixation System- STEP Series (K180226) — FDA 510 (k ..., TREND II Spinal Fixation System- STEP Series… - FDA.report, TREND II Spinal Fixation System- STEP Series - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K180226	Class II	Active

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Manufacturer

Manufacturer: Paonan Biotech Co., Ltd.

Sources (2)

FDA 510(k) K180226 24 fields · synced Sep 27, 2026
FDA UDI 7ccd5561-b9b1-4dd4-a31c-6ed6f9cae961 36 fields · synced May 27, 2026