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CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S 6112-4040

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 Number08806344344082 UDI-DI Date3 Jul 2017ListedStatusListed 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  • Withdrawn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
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
6112-4040
Primary DI / UDI-DI
08806344344082
FDA Product Code
KWP, NKG
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050, 888.3075
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

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

Other properties (10)

  • 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