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Fuse ULTRA FOOT PLATING SYSTEM OS328010

by CPM Medical Consultants, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K141784; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB565OS3280101 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0230-2026 FDA Class II initiated 17 Sep 2025 on shared 510(k) K141784

    Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

    • Terminated Z-0026-2016 FDA Class II initiated 14 Jul 2015 on shared 510(k) K141784

    Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fuse ULTRA FOOT PLATING SYSTEM
Generic Name
Orthopaedic bone calliper
Model / Ref / Catalog
OS328010
Primary DI / UDI-DI
B565OS3280101
510(k) Number
FDA Product Code
HTJ
GMDN Term
Orthopaedic bone calliper
Device Class
Class I
Regulation Number
888.4300
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K141784)

Show all (12)

Other devices from CPM Medical Consultants, LLC

See all devices from CPM Medical Consultants, LLC →

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