Skip to content

Pediatric Nailing Platform | Tibia 00-1524-0475

by Orthopediatrics Corp.

Ref 00-1524-0475Model 00-1524-0015

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084113211510TiSCREWHS Basic UDI-DI 00840194427067UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840194427067 UDI-DI Date15 Sep 2023ListedStatusListed 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 23 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  • Withdrawn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 Pediatrics Nailing Platform|Tibia System EUDAMED
Pediatric Nailing Platform | Tibia GUDID
Generic Name
Orthopaedic bone screw (non-sliding)
Device Name
PNP 4.0mm x 15mm Fully Threaded Screw, Ti
Model / Ref / Catalog
00-1524-0475, 00-1524-0015
Primary DI / UDI-DI
00840194427067
Basic UDI-DI
084113211510TiSCREWHS
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120604 Osteosynthesis nail-screw systems
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K231266)

Show all (12)

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: 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