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Vertefix II CZE5550MX

by Elite Surgical Supplies (Pty) Ltd

Vertefix II CZE5550MX is a Class II device made by Elite Surgical Supplies (Pty) Ltd, listed in FDA GUDID since 23 Sep 2016 (UDI-DI 06009696227191), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06009696227191 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Vertefix II
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
CZE5550MX
Primary DI / UDI-DI
06009696227191
FDA product code
MNH, MNI
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Similar devices

Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

Other devices from Elite Surgical Supplies (Pty) Ltd

See all devices from Elite Surgical Supplies (Pty) Ltd →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)