ANKYRAS

FDA 510(k) Premarket Notification · Submission K250160 · Applicant: Mentice Spain S.L.

Public Record 510(k) Submission Decision Date: 2025-05-06 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K250160.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K250160

Applicant / Sponsor

Mentice Spain S.L.

Device Name

ANKYRAS

Product Code

PZO

Decision Date

2025-05-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-01-21

Related Establishments / Registrations

ISCHEMAVIEW, INC. Registration: 3011205675 View Registration
SIM&CURE Registration: 3015978024 View Registration
MENTICE SPAIN S.L. Registration: 3038611208 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.