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510(k) K100698

STCC by Cardinal Spine, LLC — Product Code ODP

K100698 is an FDA 510(k) premarket notification submitted by Cardinal Spine, LLC for the device "STCC". The FDA issued a decision of Substantially Equivalent on March 14, 2011. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Cardinal Spine, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2011
Date Received
March 11, 2010
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 Cardinal Spine, LLC

  • K152568 — C-VBR (February 11, 2016)
  • K142030 — STGC-LORDOTIC (January 23, 2015)
  • K121176 — STGC (August 17, 2012)

Other clearances for product code ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (August 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • 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)

FDA data resources