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LnK Spinal Fixation System 1054-5050

by L&K Biomed Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806189854500 UDI-DI Date30 Sep 2014ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
LnK Spinal Fixation System
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
1054-5050
Primary DI / UDI-DI
08806189854500
FDA product code
KWP, KWQ, MNH, MNI, NKB
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3050, 888.3060, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system rod

Other devices from L&K Biomed

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No