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Mako 210490

by MAKO Surgical Corp.

Ref 210490Model 08858251002217SD

Mako 210490 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 5 Aug 2026 (Basic UDI-DI 08858251002217SD) and listed in FDA GUDID since 6 Feb 2025 (UDI-DI 07613327523874), 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 Number08858251002217SD Basic UDI-DI 07613327523874UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327523874 UDI-DI Date6 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002217SD registered 5 Aug 2026 Active
  • FDA GUDID UDI-DI 07613327523874 listed 6 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327523874
  2. Registered EUDAMED 08858251002217SD

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  • Withdrawn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
Sawing power tool attachment, reciprocating
Device name
TD-01 - MAKO - Class IIa - Saw/Reamer
Model / Ref / Catalog
210490, 08858251002217SD
Description
MICS Sagittal Saw Attachment , Angled
Primary DI / UDI-DI
07613327523874
Basic UDI-DI
08858251002217SD
FDA product code
OLO
EMDN code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN term
Sawing power tool attachment, reciprocating
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
Sterilisation method
Moist Heat or Steam Sterilization

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: Sawing power tool attachment, reciprocating

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)