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PediNail 00-1500-5080

by Orthopediatrics Corp.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841132129319 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

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

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
00-1500-5080
Primary DI / UDI-DI
00841132129319
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)

Show all (12)

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains latex: 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