Skip to content

Cortical Screw, D=4.5mm, L=115mm, Cort. Thread 32455-115

by I.T.S. GmbH GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09120047298541 UDI-DIDate1 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Cortical Screw, D=4.5mm, L=115mm, Cort. Thread
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
32455-115
Primary DI / UDI-DI
09120047298541
510(k) Number
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K260054)

Show all (12)

Other devices from I.T.S. GmbH

See all devices from I.T.S. GmbH →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: 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