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OrthoPediatrics Cannulated Screw System 01-1400-2015

by Orthopediatrics Corp.

Ref 01-1400-2015Model 01-1007-0036

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 Number08411321CIIADRV62 Basic UDI-DI 00841132173633UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132173633 UDI-DI Date3 Sep 2019ListedStatusListed 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  • Withdrawn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
OrthoPediatrics Cannulated Screw System GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Orthopediatrics® Instrumentation
Model / Ref / Catalog
01-1400-2015, 01-1007-0036
Primary DI / UDI-DI
00841132173633
Basic UDI-DI
08411321CIIADRV62
510(k) Number
FDA Product Code
HWC
EMDN Code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3040
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 IIa
GUDID
Class II

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K190324)

Show all (12)

Other devices from Orthopediatrics Corp.

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Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: 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