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LnK Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
LnK Spinal Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
L&K Biomed Side Click Connector, One by one L:28, W:9, D1:5.2,D2:5.7 1EA FDA UDI
Model / Reference
1828-5257 FDA UDI
Description
L&K Biomed Side Click Connector, One by one L:28, W:9, D1:5.2,D2:5.7 1EA FDA UDI

Identifiers

Catalog Number
1828-5257 FDA UDI
Primary DI / UDI-DI
08806189864547 FDA UDI
FDA Product Code
MNI FDA UDI
NKB FDA UDI
KWQ FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
888.3050 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 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.

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 a12c224c-c5cb-4cb8-9c9a-ecc0314c4b63 34 fields · synced May 31, 2026