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Mako 213951

by MAKO Surgical Corp.

Ref 213951Model 08858251002272SM

Mako 213951 is a device classified as Class IIa in the EU and Class II in the US made by MAKO Surgical Corp., registered in EUDAMED on 20 May 2026 (Basic UDI-DI 08858251002272SM), cleared under FDA 510(k) K191998 on 24 Sep 2019 and listed in FDA GUDID since 30 Mar 2021 (UDI-DI 07613327395341), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191998

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002272SM Basic UDI-DI 07613327395341UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327395341 UDI-DI Date30 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191998 Date24 Sep 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002272SM registered 20 May 2026 Active
  • FDA 510(k) K191998 decided 24 Sep 2019 Active
  • FDA GUDID UDI-DI 07613327395341 listed 30 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191998
  2. Listed FDA GUDID 07613327395341
  3. Registered EUDAMED 08858251002272SM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mako
Generic name
Robotic surgical navigation system application software
Device name
TD-04 - MAKO - Class IIa - Software Discs
Model / Ref / Catalog
213951, 08858251002272SM
Primary DI / UDI-DI
07613327395341
Basic UDI-DI
08858251002272SM
Direct marketing DI
07613327395341
510(k) Number
FDA product code
OLO
EMDN code
Z12130482 Stereotactic orthopaedic surgery instruments - software accessories
GMDN term
Robotic surgical navigation system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Robotic surgical navigation system application software

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Reusable
  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)