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PediNail 00-1500-6532

by Orthopediatrics Corp.

Ref 00-1500-6532Model 00-1500-6530

PediNail 00-1500-6532 is a device classified as Class IIb in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 0841132115002S), cleared under FDA 510(k) K083726 on 11 Mar 2009 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00841132129449), active as of 25 Oct 2026. 27 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

27 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083726

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841132115002S Basic UDI-DI 00841132129449UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132129449 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083726 Date11 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0841132115002S registered 21 Jul 2026 Active
  • FDA 510(k) K083726 decided 11 Mar 2009 Active
  • FDA GUDID UDI-DI 00841132129449 listed 31 Oct 2016 Listed

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.

Timeline

30 dated events

  1. Recall initiated FDA recalls Z-0349-2010
  2. Recall initiated FDA recalls Z-0345-2010
  3. Recall initiated FDA recalls Z-0363-2010
  4. Recall initiated FDA recalls Z-0342-2010
  5. Recall initiated FDA recalls Z-0350-2010
  6. Recall initiated FDA recalls Z-0364-2010
  7. Recall initiated FDA recalls Z-0361-2010
  8. Listed FDA GUDID 00841132129449
  9. Recall initiated FDA recalls Z-0879-2017
  10. Registered EUDAMED 0841132115002S

20 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Orthopediatrics® Pedinail™ Intramedullary Nailing System EUDAMED
PediNail GUDID
Generic name
Orthopaedic bone bolt
Model / Ref / Catalog
00-1500-6532, 00-1500-6530
Primary DI / UDI-DI
00841132129449
Basic UDI-DI
0841132115002S
510(k) Number
FDA product code
HSB
EMDN code
P09120604 Osteosynthesis nail-screw systems
GMDN term
Orthopaedic bone bolt
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841132129449: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone bolt

Cleared under the same submission (K083726)

and 8 more cleared under K083726

Similar devices

Also classified as Orthopaedic bone bolt.

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS NAIL-SCREW SYSTEMS.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)