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ANKYRAS v4.0.4-US

by Mentice Spain S.L.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08437025622016 UDI-DI Date26 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ankyras
Generic Name
Surgical simulation system
Model / Reference
v4.0.4-US
Primary DI / UDI-DI
08437025622016
510(k) Number
FDA Product Code
PZO
GMDN Term
Surgical simulation system
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Mentice Spain S.L.

  • Ankyras

    Class II

  • Ankyras

    Class II

Properties

  • Prescription Use
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No