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510(k) K172446

SPIRA-C Open Matrix Cervical Interbody by Camber Spine Technologies — Product Code ODP

K172446 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "SPIRA-C Open Matrix Cervical Interbody". The FDA issued a decision of Substantially Equivalent on November 7, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Camber Spine Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2017
Date Received
August 14, 2017
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 Camber Spine Technologies

  • K234077 — SPIRA® Anterior Lumbar Spacers (July 12, 2024)
  • K232256 — Alcantara Thoracolumbar Plate System (April 16, 2024)
  • K233972 — Camber Sacroiliac (SI) Fixation System (February 27, 2024)
  • K230942 — SPIRA® Posterior Lumbar Spacers (July 11, 2023)
  • K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (March 30, 2023)
  • K223837 — SPIRA®-C Integrated Fixation System (March 22, 2023)
  • K203503 — Camber Sacroiliac (SI) Fixation System (September 2, 2022)
  • K220038 — Camber Spine Navigation System (April 29, 2022)
  • K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (June 15, 2021)
  • K193153 — SPIRA-C Integrated Fixation System (April 24, 2020)

Other clearances for product code ODP

  • 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)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources