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111655

by MAKO Surgical Corp.

Ref 111655Model 08858251002253SH

111655 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 08858251002253SH) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486017323), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002253SH Basic UDI-DI 00848486017323UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486017323 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002253SH registered 5 Aug 2026 Active
  • FDA GUDID UDI-DI 00848486017323 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848486017323
  2. Registered EUDAMED 08858251002253SH

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  • Withdrawn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
Radiological image marker, implantable
Device name
TD-03 - MAKO - Class IIa - Screws - Consumables - Metal
Model / Ref / Catalog
111655, 08858251002253SH
Primary DI / UDI-DI
00848486017323
Basic UDI-DI
08858251002253SH
Direct marketing DI
00848486017323
FDA product code
OLO
EMDN code
Z12130485 Stereotactic orthopaedic surgery instruments - consumables
GMDN term
Radiological image marker, implantable
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
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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: Radiological image marker, implantable

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)