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Na 213527

by MAKO Surgical Corp.

Ref 213527Model 08858251002254SK

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

CE MDR

Valid until

Not listed

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

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 Number08858251002254SK Basic UDI-DI 07613327412376UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327412376 UDI-DI Date17 Sep 2018ListedStatusListed 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.

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  • Withdrawn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
Orthopaedic bone pin, non-bioabsorbable
Device Name
TD-03 - MAKO - Class IIa - Bone Pins - Consumables - Metal
Model / Ref / Catalog
213527, 08858251002254SK
Primary DI / UDI-DI
07613327412376
Basic UDI-DI
08858251002254SK
Direct Marketing DI
07613327412376
FDA Product Code
OLO
EMDN Code
Z12130485 Stereotactic orthopaedic surgery instruments - consumables
GMDN Term
Orthopaedic bone pin, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
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

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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