Skip to content

Sirion GZC13A08C

by Astura Medical

Sirion GZC13A08C is a Class II device made by Astura Medical, listed in FDA GUDID since 15 Jul 2021 (UDI-DI 00841379191896), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841379191896 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sirion
Generic name
Spinal implant trial
Model / Ref / Catalog
GZC13A08C
Primary DI / UDI-DI
00841379191896
FDA product code
OVD, KWQ, MAX
GMDN term
Spinal implant trial
Device class
Class II
Regulation number
888.3080, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 18 Millimeter
Height — 8 Millimeter
Angle — 12 degree

Related devices

Category: Spinal implant trial

Similar devices

Other devices filed under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Other devices from Astura Medical

See all devices from Astura Medical →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)