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Panta 500080ND

by Newdeal Sas

Panta 500080ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K091788 on 29 Jul 2009 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780044505), active as of 23 Oct 2026. 2 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

2 closed

Documents

510(k) K091788

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 Number10381780044505 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK091788 Date29 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091788 decided 29 Jul 2009 Active
  • FDA GUDID UDI-DI 10381780044505 listed 9 Oct 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1539-2017 FDA Class II initiated 3 Mar 2017

    Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

    • Terminated Z-1736-2013 FDA Class II initiated 9 May 2013

    As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.

Timeline

4 dated events

  1. Cleared FDA 510(k) K091788
  2. Recall initiated FDA recalls Z-1736-2013
  3. Recall initiated FDA recalls Z-1539-2017
  4. Listed FDA GUDID 10381780044505

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Panta
Generic name
Arthrodesis intramedullary nail, non-distracting
Model / Ref / Catalog
500080ND
Primary DI / UDI-DI
10381780044505
510(k) Number
FDA product code
HSB
GMDN term
Arthrodesis intramedullary nail, non-distracting
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Cleared under the same submission (K091788)

and 8 more cleared under K091788

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)