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LnK Spinal Instrument System SI01-0204

by L&K Biomed Co., Ltd.

Ref SI01-0204

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800108688429 Basic UDI-DI 08800108688429UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800108688429 UDI-DI Date23 Aug 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
LnK Spinal Instrument System
Generic Name
Cannulated surgical drill bit, reusable
Device Name
Cannulated Drill ⌀5.4
Model / Ref / Catalog
SI01-0204
Primary DI / UDI-DI
08800108688429
Basic UDI-DI
B-08800108688429
FDA Product Code
LXH
EMDN Code
L0927 Orthopaedic surgery manual perforators, reusable
GMDN Term
Cannulated surgical drill bit, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Cannulated surgical drill bit, reusable

Other devices from L&K Biomed

See all devices from L&K Biomed →

Properties

  • Reusable
  • Premarket Exempt

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No