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Ball Probe 81717

by Premia Spine Ltd

Ball Probe 81717 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K231844 on 7 Jul 2023 (3 earlier submissions), approved under FDA PMA P220002 on 15 Jun 2023 and listed in FDA GUDID since 3 Sep 2024 (UDI-DI 07290115932676), active as of 22 Oct 2026. One FDA recall is linked to it.

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

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115932676 UDI-DI Date3 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK231844 Date7 Jul 2023DecidedStatusActive
United StatesFDA PMAAPPR from GUDID Approved NumberP220002 Date15 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231844 decided 7 Jul 2023 Active· +3 more in the status table
  • FDA PMA P220002 decided 15 Jun 2023 Active
  • FDA GUDID UDI-DI 07290115932676 listed 3 Sep 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2516-2025 FDA Class II initiated 16 Jul 2025

    Potential for missing pins at tip of inserter.

Timeline

7 dated events

  1. Cleared FDA 510(k) K150380
  2. Cleared FDA 510(k) K170061
  3. Cleared FDA 510(k) K182598
  4. Approved FDA PMA P220002
  5. Cleared FDA 510(k) K231844
  6. Listed FDA GUDID 07290115932676
  7. Recall initiated FDA recalls Z-2516-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k), FDA PMA Active

Specification

GUDID

Trade name
Ball Probe
Generic name
Abdominal/ENT/orthopaedic surgical probe, reusable
Model / reference
81717
Primary DI / UDI-DI
07290115932676
PMA number
510(k) Number
FDA product code
NKB, MNH, MNI, QWK
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Abdominal/ENT/orthopaedic surgical probe, reusable

Cleared under the same submission (K150380)

and 8 more cleared under K150380

Cleared under the same submission (K170061)

and 8 more cleared under K170061

Similar devices in this category

Other devices filed under Abdominal/ENT/orthopaedic surgical probe, reusable.

Other devices from Premia Spine Ltd

See all devices from Premia Spine Ltd →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)