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Mako 1.0

by MAKO Surgical Corp. 2 variants

Ref 190687Model 08858251002257SR

Mako 1.0 (190687) 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 21 May 2026 (Basic UDI-DI 08858251002257SR) and listed in FDA GUDID since 15 Nov 2024 (UDI-DI 07613327626971), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002257SR Basic UDI-DI 07613327626971UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327626971 UDI-DI Date15 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002257SR registered 21 May 2026 Active
  • FDA GUDID UDI-DI 07613327626971 listed 15 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327626971
  2. Registered EUDAMED 08858251002257SR

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  • Withdrawn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
Optical surgical tracking system spatial marker, single-use
Device name
TD-03 - MAKO - Class IIa - Tracker - Consumables - Metal and Plastic
Model / Ref / Catalog
08858251002257SR, 190687, 1.0
Primary DI / UDI-DI
07613327626971
Basic UDI-DI
08858251002257SR
FDA product code
OLO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Optical surgical tracking system spatial marker, single-use
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002257SR
190687
GUDID
1.0
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: Surgical optical-tracking spatial marker, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)