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Point Robotics Medtech Inc. PSNI01-401

by Point Robotics MedTech, Inc.

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 Number04719881650452 UDI-DI Date13 Apr 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  • Withdrawn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
Point Robotics Medtech Inc.
Generic Name
Orthopaedic stereotactic surgery system
Model / Reference
PSNI01-401
Primary DI / UDI-DI
04719881650452
510(k) Number
FDA Product Code
OLO
GMDN Term
Orthopaedic stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252989)

Show all (12)

Other devices from Point Robotics MedTech, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No