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LnK/OpenLoc-L Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
LnK/OpenLoc-L Spinal Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Crosslink 34-42mm FDA UDI
Model / Reference
1043-0042 FDA UDI
Description
Crosslink 34-42mm FDA UDI

Identifiers

Primary DI / UDI-DI
08806344397125 FDA UDI
510(k) Number
K183168 FDA UDI
FDA Product Code
KWQ FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system connector

LnK/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 Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K183168 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
L&K Biomed Co. , Ltd.

Sources (1)

  • FDA UDI 11dc95c8-20b4-48a8-aa60-e1e8f23918b6 34 fields · synced May 30, 2026