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MIS Tower Guide 86261N

by Premia Spine Ltd

MIS Tower Guide 86261N 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 1 Jun 2026 (UDI-DI 07290115935837), active (FDA 510(k), FDA PMA), not in commercial distribution (GUDID) as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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 Number07290115935837 UDI-DI Date1 Jun 2026ListedStatusListed GUDID: not 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 07290115935837 listed 1 Jun 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 07290115935837

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  • Withdrawn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
MIS Tower Guide
Generic name
Orthopaedic implant aiming/guiding block attachment tool
Model / reference
86261N
Primary DI / UDI-DI
07290115935837
PMA number
510(k) Number
FDA product code
NKB, MNH, MNI, QWK
GMDN term
Orthopaedic implant aiming/guiding block attachment tool
Device class
Class II
Regulation number
888.3070
GUDID distribution status
Not 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)