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PediNail Intramedullary Platform 00-1506-2047

by Orthopediatrics Corp.

Ref 00-1506-2047Model 00-1500-6530

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

3 closed

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 Number0841132115002S Basic UDI-DI 00841132147962UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132147962 UDI-DI Date31 May 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.

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0219-2020 FDA Class II initiated 19 Aug 2019
    • Terminated Z-0218-2020 FDA Class II initiated 19 Aug 2019

    Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

    • Terminated Z-0125-2020 FDA Class II initiated 19 Aug 2019

    Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

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  • Withdrawn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® Pediatric Nailing Platform|Femur System EUDAMED
PediNail Intramedullary Platform GUDID
Generic Name
Femur intramedullary nail
Device Name
Orthopediatrics® Pedinail™ Intramedullary Nailing System
Model / Ref / Catalog
00-1506-2047, 00-1500-6530
Primary DI / UDI-DI
00841132147962
Basic UDI-DI
0841132115002S
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120604 Osteosynthesis nail-screw systems
GMDN Term
Femur intramedullary nail
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K172583)

Show all (12)

Other devices from Orthopediatrics Corp.

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Properties

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

Other properties (19)

  • 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