OpenLoc-L Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name: OpenLoc-L Spinal Fixation System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Poly Axial Screw Ø4.0, 50mm FDA UDI
Model / Reference: 1324-4050 FDA UDI
Description: Poly Axial Screw Ø4.0, 50mm FDA UDI

Identifiers

Catalog Number: 1324-4050 FDA UDI
Primary DI / UDI-DI: 08806344353725 FDA UDI
FDA Product Code: KWQ FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw, non-bioabsorbable

OpenLoc-L Spinal Fixation System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

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ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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
EVEREST® Spinal System — K2M, INC. · Class II
Insignia — ALPHATEC SPINE, INC. · Class II

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: L&K Biomed Co. , Ltd.

Sources (1)

FDA UDI 60f32429-60bd-49d5-8e7c-6e8364cd5a49 34 fields · synced May 30, 2026