LineSider

FDA UDI

Class II (US FDA UDI)

by Integrity Implants Inc.

Identity

Trade Name: LineSider FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Non-cannulated - 8.5mm x 55mm FDA UDI
Model / Reference: LS-N6MA8555 FDA UDI
Description: 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Non-cannulated - 8.5mm x 55mm FDA UDI

Identifiers

Catalog Number: LS-N6MA8555 FDA UDI
Primary DI / UDI-DI: 00818613025200 FDA UDI
510(k) Number: K203367 FDA UDI
FDA Product Code: NKB FDA UDI
KWP FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 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: Spinal bone screw, non-bioabsorbable

Integrity Implants' LineSider spinal fixation device is a small, threaded implantable rod designed to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. Available in various types with different drives, it offers customizable solutions for surgeons.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, 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 3c85bca9-a2db-4fdd-8ced-68f95c65db34 36 fields · synced Jul 11, 2026