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eZ-Fix 810-70

by Orthopediatrics Corp.

Ref 810-70Model 01-1007-0038

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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 Number084113210999SSNCIS5 Basic UDI-DI 00841132142868UDI-DIDate8 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132142868 UDI-DI Date28 Feb 2020ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Orthopediatrics® Orthex External Fixation System Instructions for Use EUDAMED
eZ-Fix GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Device Name
Orthopediatrics® Instrumentation
Model / Ref / Catalog
810-70, 01-1007-0038
Primary DI / UDI-DI
00841132142868
Basic UDI-DI
084113210999SSNCIS5
510(k) Number
FDA Product Code
KTT
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
External orthopaedic fixation system noninvasive component, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: External orthopaedic fixation system noninvasive component, single-use

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Other devices from Orthopediatrics Corp.

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Properties

  • Single Use
  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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