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XL Screwdriver CM 89197

by Premia Spine Ltd

XL Screwdriver CM 89197 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 20 Oct 2026 (UDI-DI 07290115935905), active as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115935905 UDI-DI Date20 Oct 2026ListedStatusListed 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 07290115935905 listed 20 Oct 2026 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. Recall initiated FDA recalls Z-2516-2025
  7. Listed FDA GUDID 07290115935905

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  • Withdrawn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
XL Screwdriver CM
Generic name
Surgical screwdriver, reusable
Model / reference
89197
Primary DI / UDI-DI
07290115935905
PMA number
510(k) Number
FDA product code
NKB, MNI, MNH, QWK
GMDN term
Surgical screwdriver, reusable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K150380)

and 8 more cleared under K150380

Cleared under the same submission (K170061)

and 8 more cleared under K170061

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)