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Tower Guide ST 86261N

by Premia Spine Ltd GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115932508 UDI-DIDate23 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing 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.

Specification

GUDID

Trade Name
Tower Guide ST
Generic Name
Orthopaedic implant aiming/guiding block attachment tool
Model / Reference
86261N
Primary DI / UDI-DI
07290115932508
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
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No