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Na 112210

by MAKO Surgical Corp.

Ref 112210Model 08858251002247SN

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002247SN Basic UDI-DI 00848486002909UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486002909 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mako
Generic Name
Patient positioning sensor
Device Name
TD-01 - MAKO - Class I - Stereotactic Orthopedic Surgery Instruments - Metal
Model / Ref / Catalog
112210, 08858251002247SN
Primary DI / UDI-DI
00848486002909
Basic UDI-DI
08858251002247SN
Direct Marketing DI
00848486002909
FDA Product Code
OLO
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Patient positioning sensor
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Patient positioning sensor

Cleared under the same submission (K112507)

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Other devices from MAKO Surgical Corp.

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Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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