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LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System 3922-1612S

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 Number08806344382886 UDI-DI Date22 Jan 2019ListedStatusListed 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  • Withdrawn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 Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System
Generic Name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
3922-1612S
Primary DI / UDI-DI
08806344382886
510(k) Number
FDA Product Code
MAX
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K181380)

Show all (12)

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Properties

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

Other properties (8)

  • 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