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510(k) K123717

UCENTUM by Ulrich GmbH & Co. KG — Product Code NKB

K123717 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "UCENTUM". The FDA issued a decision of SESU on March 4, 2013. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
March 4, 2013
Date Received
December 4, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Ulrich GmbH & Co. KG

  • K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (November 18, 2025)
  • K251295 — ulrichINJECT CT Motion (XD 8000) (November 7, 2025)
  • K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (August 26, 2024)
  • K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (April 19, 2024)
  • K210541 — ulrichINJECT CT motion (August 6, 2021)
  • K202227 — Artus™ cervical plate system (September 14, 2020)
  • K192872 — ulrichINJECT CT Motion (July 2, 2020)
  • K192117 — Small VBR™ (November 1, 2019)
  • K171392 — ulrichINJECT CT motion (November 9, 2017)
  • K161032 — neon3™ universal OCT spinal stabilization (December 22, 2016)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources