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PediNail 00-1500-5064

by Orthopediatrics Corp.

PediNail 00-1500-5064 is a Class II device made by Orthopediatrics Corp., cleared under FDA 510(k) K083726 on 11 Mar 2009 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00841132129210), active as of 23 Oct 2026. 27 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

27 closed

Documents

510(k) K083726

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841132129210 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083726 Date11 Mar 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083726 decided 11 Mar 2009 Active
  • FDA GUDID UDI-DI 00841132129210 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

29 dated events

  1. Recall initiated FDA recalls Z-0358-2010
  2. Recall initiated FDA recalls Z-0349-2010
  3. Recall initiated FDA recalls Z-0345-2010
  4. Recall initiated FDA recalls Z-0363-2010
  5. Recall initiated FDA recalls Z-0342-2010
  6. Recall initiated FDA recalls Z-0350-2010
  7. Recall initiated FDA recalls Z-0364-2010
  8. Recall initiated FDA recalls Z-0361-2010
  9. Listed FDA GUDID 00841132129210
  10. Recall initiated FDA recalls Z-0879-2017

19 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PediNail
Generic name
Orthopaedic bone bolt
Model / Ref / Catalog
00-1500-5064
Primary DI / UDI-DI
00841132129210
510(k) Number
FDA product code
HSB
GMDN term
Orthopaedic bone bolt
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

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.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)