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LnK/CastleLoc-S Posterior Cervical Fixation System 6111-4528

by L&K Biomed Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08800108645989 UDI-DI Date3 May 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LnK/CastleLoc-S Posterior Cervical Fixation System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
6111-4528
Description
Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x28mm
Primary DI / UDI-DI
08800108645989
510(k) Number
FDA Product Code
NKG, KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3075, 888.3050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K200793)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • 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