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OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-054

by Orthopediatrics Corp.

Ref 10-1500-054Model 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

27 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841132115002S Basic UDI-DI 00841132118924UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132118924 UDI-DI Date1 Sep 2015ListedStatusListed 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

27 recalls · FDA

    • Terminated Z-0879-2017 FDA Class III initiated 18 Nov 2016

    Labeled as a 48mm Cortical Screw but measuring at 50mm

  • 26 recalls, same reason

    • Terminated Z-0341-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0348-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0354-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0353-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0351-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0359-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0352-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0344-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0362-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0343-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-034-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0356-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0346-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0355-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0357-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0339-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0347-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0360-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0358-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0349-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0345-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0363-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0342-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0350-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0364-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0361-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009

    The potential exists for the nails to fracture during insertion of the nail.

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® Pedinail™ Intramedullary Nailing System EUDAMED
OrthoPediatrics PediNail Intramedullary Nailing System GUDID
Generic Name
Femur intramedullary nail
Model / Ref / Catalog
10-1500-054, 00-1500-6530
Primary DI / UDI-DI
00841132118924
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 (K083726)

Show all (12)

Other devices from Orthopediatrics Corp.

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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