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uCentum™ comprehensive posterior system CS 3885-075-060

by Ulrich GmbH & Co. KG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Overview

The uCentum comprehensive posterior system is a longarm screw, polyaxial orthotic device designed for internal spinal fixation in the treatment of spinal instabilities or deformities. This implantable rod provides immobilization and stabilization of the spine, allowing for correction and stabilisation of damaged bone segments.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04052536083213 UDI-DI Date30 Jul 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1126-2019 FDA Class II initiated 8 Mar 2019 on shared 510(k) K123717

    Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

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  • Withdrawn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
uCentum™ comprehensive posterior system
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
CS 3885-075-060
Primary DI / UDI-DI
04052536083213
510(k) Number
FDA Product Code
MNH, NKB, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K123717)

Show all (12)

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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