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510(k) K192897

icotec Cervical Cage by Icotec AG — Product Code ODP

K192897 is an FDA 510(k) premarket notification submitted by Icotec AG for the device "icotec Cervical Cage". The FDA issued a decision of Substantially Equivalent on March 20, 2020. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Icotec AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2020
Date Received
October 11, 2019
Clearance Type
Traditional
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 Icotec AG

  • K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments (November 12, 2025)
  • K242900 — VADER® Pedicle System and VADER®one Pedicle System (February 27, 2025)
  • K233215 — icotec Anterior Cervical Plate System (May 17, 2024)
  • K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, ico (April 5, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K232628 — VADER® Pedicle System (February 26, 2024)
  • K230861 — VADER® Pedicle System Navigated Instruments (June 27, 2023)
  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 2023)
  • K201587 — icotec Anterior Cervical Plate System (October 15, 2020)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)

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