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510(k) K222004

INTEGRATE -C Interbody Fusion System by Happe Spine — Product Code ODP

K222004 is an FDA 510(k) premarket notification submitted by Happe Spine for the device "INTEGRATE -C Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on Apr 28, 2023. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 28, 2023
Date Received
Jul 7, 2022
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
510(k)

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

Other clearances for product code ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (Aug 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (Aug 18, 2026)
  • K253041 — 3d Cage Cervical (Jul 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… (Jul 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (Jul 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 (Apr 24, 2026)
  • K253260 — ORIO-3D Cage System (Apr 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES… (Apr 13, 2026)

FDA data resources