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Threaded Spherz 2020-40

by Izi Medical Products LLC

Threaded Spherz 2020-40 is a Class II device made by Izi Medical Products LLC, cleared under FDA 510(k) K022074 on 13 Aug 2002 and listed in FDA GUDID since 29 Nov 2016 (UDI-DI 00815212021565), active as of 22 Oct 2026. 23 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

25 closed

Documents

510(k) K022074

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815212021565 UDI-DI Date29 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK022074 Date13 Aug 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K022074 decided 13 Aug 2002 Active
  • FDA GUDID UDI-DI 00815212021565 listed 29 Nov 2016 Listed

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1587-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1581-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1582-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1600-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1584-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1601-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1578-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1580-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1591-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1590-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1595-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1594-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1593-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1596-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1598-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1592-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1589-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1585-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1579-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1602-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1583-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K022074
    • Terminated Z-1599-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1588-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K022074
    • Terminated Z-1597-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1586-2014 FDA Class II initiated 24 Apr 2014

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

27 dated events

  1. Recall initiated FDA recalls Z-1589-2014
  2. Recall initiated FDA recalls Z-1585-2014
  3. Recall initiated FDA recalls Z-1579-2014
  4. Recall initiated FDA recalls Z-1602-2014
  5. Recall initiated FDA recalls Z-1583-2014
  6. Recall initiated FDA recalls Z-1599-2014
  7. Recall initiated FDA recalls Z-1588-2014
  8. Recall initiated FDA recalls Z-1597-2014
  9. Recall initiated FDA recalls Z-1586-2014
  10. Listed FDA GUDID 00815212021565

17 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
Threaded Spherz
Generic name
Radiographic image marker, manual
Model / reference
2020-40
Primary DI / UDI-DI
00815212021565
510(k) Number
FDA product code
HAW
GMDN term
Radiographic image marker, manual
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiographic image marker, manual

Cleared under the same submission (K022074)

and 8 more cleared under K022074

Similar devices in this category

Other devices filed under Radiographic image marker, manual.

Other devices from Izi Medical Products LLC

See all devices from Izi Medical Products LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)