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510(k) K241396

uCerv Flux™-C 3D Porous Titanium Cervical Interbody by Ulrich Medical USA, Inc. — Product Code ODP

K241396 is an FDA 510(k) premarket notification submitted by Ulrich Medical USA, Inc. for the device "uCerv Flux™-C 3D Porous Titanium Cervical Interbody". The FDA issued a decision of Substantially Equivalent on May 23, 2024. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Ulrich Medical USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2024
Date Received
May 16, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Ulrich Medical USA, Inc.

  • K252087 — Navigation Module of the Cortium® System (February 3, 2026)
  • K251719 — Momentum® Posterior Spinal Fixation System (July 1, 2025)
  • K240515 — uNion® MAX Cervical Plate System (March 18, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K230614 — Cortium™ (May 2, 2023)
  • K223274 — Momentum® MIS Posterior Spinal Fixation System (November 28, 2022)
  • K220696 — uCerv Flux-C 3D Porous Titanium Cervical Interbody (August 19, 2022)
  • K200845 — Navigation Module of the Momentum System (September 10, 2020)
  • K191932 — Momentum™ Posterior Spinal Fixation System (October 2, 2019)
  • K181921 — Solidity Vertebral Body Replacement (November 16, 2018)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources