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Athena II Cervical Plate System APS3518WS

by Medyssey Co., Ltd. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800048413860 UDI-DIDate9 Jul 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Athena II Cervical Plate System
Generic Name
Spinal fixation plate, non-bioabsorbable
Model / Reference
APS3518WS
Primary DI / UDI-DI
08800048413860
FDA Product Code
KWQ
GMDN Term
Spinal fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Single Use
  • Implantable

Other properties (12)

  • Sterile: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No