Sirion GM1655FHF

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	Number00840085252396 UDI-DI	Date22 May 2023Listed	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Withdrawn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: Metallic spinal interbody fusion cage
Model / Ref / Catalog: GM1655FHF

Primary DI / UDI-DI: 00840085252396
FDA Product Code: KWQ, OVD, MAX
GMDN Term: Metallic 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: Length — 55 Millimeter
Width — 16 Millimeter
Height — 12 Millimeter
Angle — 25 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