Sirion GA204510D

by Astura Medical GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841379192671 UDI-DI	Date6 Jul 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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Withdrawn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: Sirion
Generic Name: Polymeric spinal interbody fusion cage
Model / Ref / Catalog: GA204510D

Primary DI / UDI-DI: 00841379192671
FDA Product Code: KWQ, MAX, OVD
GMDN Term: Polymeric spinal interbody fusion cage

Device Class: Class II
Regulation Number: 888.3060, 888.3080
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Angle — 15 degree
Length — 45 Millimeter
Width — 20 Millimeter
Height — 10 Millimeter

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

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