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 Ø7.0, 130mm FDA UDI
Model / Reference: 1323-70130 FDA UDI
Description: Poly Axial Screw Ø7.0, 130mm FDA UDI

Identifiers

Catalog Number: 1323-70130 FDA UDI
Primary DI / UDI-DI: 08806344352803 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.

4CIS® Chiron Spinal Fixation System — ALPHANOX 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
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: L&K Biomed Co. , Ltd.

Sources (1)

FDA UDI b28b090a-3bc4-405d-8a93-2b7ac104a8cb 34 fields · synced Jun 1, 2026