Skip to content

Na 206693

by MAKO Surgical Corp.

Ref 206693Model 08858251002246SL

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

3 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 Number08858251002246SL Basic UDI-DI 00848486032135UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486032135 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

3 recalls · FDA

    • Terminated Z-2745-2020 FDA Class II initiated 9 Jul 2020

    Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

    • Terminated Z-3131-2017 FDA Class II initiated 7 Aug 2017

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

    • Terminated Z-1411-2017 FDA Class II initiated 22 Dec 2016

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

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  • Withdrawn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
Electrosurgical handpiece/electrode holder, reusable
Device Name
TD-01 - MAKO - Class I - Stereotactic Orthopedic Surgery Instruments - Plastic
Model / Ref / Catalog
206693, 08858251002246SL
Primary DI / UDI-DI
00848486032135
Basic UDI-DI
08858251002246SL
Direct Marketing DI
00848486032135
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Electrosurgical handpiece/electrode holder, reusable
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: Electrosurgical handpiece/electrode holder, reusable

Cleared under the same submission (K141989)

Show all (12)

Similar devices

Also classified as Electrosurgical handpiece/electrode holder, reusable.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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