Sirion GA246508B

by Astura Medical GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841379190776 UDI-DI	Date7 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Withdrawn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: GA246508B

Primary DI / UDI-DI: 00841379190776
FDA Product Code: MAX, OVD, KWQ
GMDN Term: Polymeric spinal interbody fusion cage

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

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 65 Millimeter
Width — 24 Millimeter
Height — 8 Millimeter
Angle — 7 degree

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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