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Na 111758

by MAKO Surgical Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 closed

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 Number00848486017354 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

    • Terminated Z-2924-2018 FDA Class II initiated 24 Jul 2018

    Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

    • Terminated Z-3130-2017 FDA Class II initiated 7 Aug 2017

    Software discrepancy of not showing all the EE constants, when the screen is filled.

    • Terminated Z-2741-2017 FDA Class II initiated 7 Jun 2017

    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

    • Terminated Z-0224-2016 FDA Class II initiated 16 Jul 2015

    The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

    • Terminated Z-1128-2015 FDA Class II initiated 22 Jan 2015

    When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

    • Terminated Z-1508-2016 FDA Class II initiated 30 Apr 2014

    Revision of the field manual

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Burring power tool attachment
Model / Ref / Catalog
111758
Primary DI / UDI-DI
00848486017354
FDA Product Code
OLO
GMDN Term
Burring power tool attachment
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Burring power tool attachment

Cleared under the same submission (K112507)

Show all (12)

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No