LineSider

FDA UDI

Class II (US FDA UDI)

by Integrity Implants Inc.

Identity

Trade Name: LineSider FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Ti Rod - 6.0mm 70mm Straight FDA UDI
Model / Reference: LS-RD60D070 FDA UDI
Description: Ti Rod - 6.0mm 70mm Straight FDA UDI

Identifiers

Catalog Number: LS-RD60D070 FDA UDI
Primary DI / UDI-DI: 00810004724969 FDA UDI
510(k) Number: K190360 FDA UDI
FDA Product Code: KWP FDA UDI
NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 FDA UDI
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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system rod

Integrity Implants Inc. offers a versatile and effective bone-screw internal spinal fixation system rod, known as the LineSider, designed to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. This implantable component is available in several forms, including straight, curved, rigid, flexible, with varying diameters, allowing for small movements of the spine. The LineSider system has received FDA clearance for orthopedic use and is now commercially distributed.

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integrity Implants Inc.

Sources (1)

FDA UDI 6082ec6e-6d1b-4f2c-b8aa-de391e3ef2cb 36 fields · synced Jun 23, 2026