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LnK Spinal Instrument System

FDA UDI

Class I (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
LnK Spinal Instrument System FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
POLOY AXIAL SCREW CADDY COVER ø6.5 (60MM-150MM) FDA UDI
Model / Reference
LS04-0042 FDA UDI
Description
POLOY AXIAL SCREW CADDY COVER ø6.5 (60MM-150MM) FDA UDI

Identifiers

Primary DI / UDI-DI
08809986469458 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is designed to assist with the implantation of orthopaedic prostheses, providing precise positioning and alignment for optimal results.

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

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 67555cc5-ee39-4b18-b584-c6e5a7c0abc5 33 fields · synced Jul 25, 2026