Zion CZ0800020

by Astura Medical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841379104155 UDI-DI	Date2 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Zion
Generic Name: Orthopaedic fixation implant alignment tool
Model / Ref / Catalog: CZ0800020

Primary DI / UDI-DI: 00841379104155
510(k) Number: K160702
FDA Product Code: KWQ
GMDN Term: Orthopaedic fixation implant alignment tool

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

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Lot / Batch Number

Other properties (13)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: 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